HIRES 90K ADVANTAGE IMPLANT

COCHLEAR IMPLANT

This device is manufactured by ADVANCED BIONICS.

The following problems were reported about this device:

Date Event Type Patient Problem Device Problem
2024-07-12 Injury Appropriate Term / Code Not Available None
2024-07-08 Injury Unspecified Infection None
2024-05-29 Injury Appropriate Term / Code Not Available Adverse Event Without Identified Device or Use Problem
2024-05-14 Injury Appropriate Term / Code Not Available Adverse Event Without Identified Device or Use Problem
2024-05-06 Malfunction Appropriate Term / Code Not Available Loose or Intermittent Connection
2024-04-30 Malfunction Appropriate Term / Code Not Available Adverse Event Without Identified Device or Use Problem
2024-04-23 Injury Appropriate Term / Code Not Available Adverse Event Without Identified Device or Use Problem
2024-04-22 Injury Skin Erosion, Appropriate Term / Code Not Available Adverse Event Without Identified Device or Use Problem, Migration
2024-04-11 Malfunction Appropriate Term / Code Not Available Adverse Event Without Identified Device or Use Problem
2024-03-08 Injury Unspecified Infection None
2024-03-07 Injury Appropriate Term / Code Not Available Migration
2024-03-01 Injury Pain, Dizziness Adverse Event Without Identified Device or Use Problem
2024-03-01 Injury Pain, Dizziness Adverse Event Without Identified Device or Use Problem
2024-02-29 Malfunction Appropriate Term / Code Not Available None
2024-02-27 Injury Appropriate Term / Code Not Available Adverse Event Without Identified Device or Use Problem
2024-02-13 Malfunction Head Injury, Appropriate Term / Code Not Available Electrical /Electronic Property Problem, Intermittent Communication Failure
2024-02-12 Malfunction Appropriate Term / Code Not Available Expulsion
2024-02-08 Malfunction Pain, Discomfort Electrical /Electronic Property Problem, Electro-Static Discharge, Adverse Event Without Identified Device or Use Problem
2024-01-28 Malfunction Appropriate Term / Code Not Available Intermittent Communication Failure
2024-01-25 Injury Appropriate Term / Code Not Available Adverse Event Without Identified Device or Use Problem
2024-01-10 Injury Unspecified Infection, Necrosis Adverse Event Without Identified Device or Use Problem
2024-01-08 Malfunction Appropriate Term / Code Not Available Intermittent Communication Failure
2024-01-03 Injury Necrosis, Skin Infection Adverse Event Without Identified Device or Use Problem
2023-12-28 Injury Appropriate Term / Code Not Available Expulsion, Adverse Event Without Identified Device or Use Problem
2023-12-17 Malfunction Appropriate Term / Code Not Available None
2023-12-11 Malfunction Appropriate Term / Code Not Available None
2023-11-16 Injury Head Injury Electrical /Electronic Property Problem, Intermittent Communication Failure
2023-10-24 Injury Unspecified Infection, Swelling/ Edema Adverse Event Without Identified Device or Use Problem
2023-10-06 Injury Appropriate Term / Code Not Available Migration
2023-09-29 Injury Unspecified Infection Adverse Event Without Identified Device or Use Problem
2023-09-25 Injury Unspecified Infection Adverse Event Without Identified Device or Use Problem
2023-09-19 Injury Unspecified Infection, Appropriate Term / Code Not Available Adverse Event Without Identified Device or Use Problem
2023-09-19 Injury Unspecified Infection Adverse Event Without Identified Device or Use Problem
2023-09-14 Malfunction Tinnitus, Appropriate Term / Code Not Available Adverse Event Without Identified Device or Use Problem
2023-08-23 Injury Appropriate Term / Code Not Available Migration
2023-08-22 Injury Appropriate Term / Code Not Available Adverse Event Without Identified Device or Use Problem, Migration
2023-08-19 Injury Unspecified Infection, Appropriate Term / Code Not Available Expulsion, Migration
2023-08-01 Injury Skin Inflammation/ Irritation Adverse Event Without Identified Device or Use Problem
2023-08-01 Injury Skin Inflammation/ Irritation Adverse Event Without Identified Device or Use Problem
2023-07-29 Injury Pain, Discomfort Adverse Event Without Identified Device or Use Problem
2023-07-26 Injury Pain, Swelling/ Edema Adverse Event Without Identified Device or Use Problem
2023-07-25 Malfunction Appropriate Term / Code Not Available Electro-Static Discharge, Intermittent Communication Failure
2023-07-20 Injury Unspecified Infection, Necrosis Adverse Event Without Identified Device or Use Problem
2023-07-09 Injury Skin Infection Adverse Event Without Identified Device or Use Problem
2023-07-06 Injury Meningitis Adverse Event Without Identified Device or Use Problem
2023-06-28 Injury Unspecified Infection Adverse Event Without Identified Device or Use Problem
2023-06-27 Injury Pain Adverse Event Without Identified Device or Use Problem
2023-06-23 Injury Appropriate Term / Code Not Available Adverse Event Without Identified Device or Use Problem, Migration
2023-06-21 Injury Abscess, Unspecified Infection Adverse Event Without Identified Device or Use Problem
2023-06-09 Injury Appropriate Term / Code Not Available Expulsion
2023-06-08 Injury Pain Adverse Event Without Identified Device or Use Problem
2023-06-02 Injury Discomfort Electrical /Electronic Property Problem, Adverse Event Without Identified Device or Use Problem
2023-05-26 Injury Appropriate Term / Code Not Available Adverse Event Without Identified Device or Use Problem
2023-05-25 Injury Pain, Appropriate Term / Code Not Available Adverse Event Without Identified Device or Use Problem
2023-04-27 Malfunction Appropriate Term / Code Not Available Electrical /Electronic Property Problem, Electro-Static Discharge, Loosening of Implant Not Related to Bone-Ingrowth
2023-03-17 Injury Undesired Nerve Stimulation Adverse Event Without Identified Device or Use Problem
2023-03-07 Injury Appropriate Term / Code Not Available Mechanical Problem, Adverse Event Without Identified Device or Use Problem
2023-03-03 Injury Appropriate Term / Code Not Available Electrical /Electronic Property Problem, Output Problem, Intermittent Communication Failure
2023-03-03 Injury Pain, Discomfort Migration
2023-03-02 Injury Skin Inflammation/ Irritation Adverse Event Without Identified Device or Use Problem
2023-02-02 Injury Insufficient Information, Appropriate Term / Code Not Available Adverse Event Without Identified Device or Use Problem, Appropriate Term/Code Not Available
2023-02-01 Injury Unspecified Infection, Pain Adverse Event Without Identified Device or Use Problem
2023-02-01 Injury Ulcer Adverse Event Without Identified Device or Use Problem
2023-01-24 Injury Appropriate Term / Code Not Available, Middle Ear Inflammation Adverse Event Without Identified Device or Use Problem, Output below Specifications
2023-01-21 Injury Oversedation, Pain, Swelling/ Edema Device Slipped, Adverse Event Without Identified Device or Use Problem, Output Problem
2023-01-17 Injury Pain, Appropriate Term / Code Not Available Adverse Event Without Identified Device or Use Problem
2023-01-15 Malfunction None Output Problem, Intermittent Communication Failure
2023-01-11 Injury Failure of Implant, Appropriate Term / Code Not Available Material Integrity Problem, Migration
2022-12-30 Malfunction Insufficient Information, Appropriate Term / Code Not Available Electrical /Electronic Property Problem, Electro-Static Discharge, Insufficient Information
2022-11-17 Malfunction Appropriate Term / Code Not Available Electrical /Electronic Property Problem, Electro-Static Discharge, Output Problem
2022-11-16 Injury None Adverse Event Without Identified Device or Use Problem, Insufficient Information, Migration
2022-11-10 Injury None Adverse Event Without Identified Device or Use Problem
2022-11-10 Injury None Adverse Event Without Identified Device or Use Problem
2022-11-02 Injury Head Injury Mechanical Problem, Output Problem
2022-10-24 Injury Appropriate Term / Code Not Available Difficult to Insert, Adverse Event Without Identified Device or Use Problem
2022-10-19 Injury Unspecified Infection Adverse Event Without Identified Device or Use Problem
2022-10-05 Injury None Adverse Event Without Identified Device or Use Problem, Output below Specifications
2022-09-17 Injury Appropriate Term / Code Not Available Adverse Event Without Identified Device or Use Problem, Appropriate Term/Code Not Available
2022-09-14 Injury None Adverse Event Without Identified Device or Use Problem, Migration
2022-09-06 Injury None Adverse Event Without Identified Device or Use Problem
2022-09-01 Injury Appropriate Term / Code Not Available Adverse Event Without Identified Device or Use Problem, Output Problem
2022-08-11 Malfunction None Material Protrusion/Extrusion, Output Problem
2022-08-03 Malfunction Appropriate Term / Code Not Available Electrical /Electronic Property Problem, Electro-Static Discharge, Insufficient Information
2022-07-29 Injury None Adverse Event Without Identified Device or Use Problem
2022-07-15 Injury None Migration or Expulsion of Device, Migration
2022-07-05 Injury None Migration or Expulsion of Device, Expulsion
2022-06-22 Injury None Migration or Expulsion of Device, Migration, Intermittent Communication Failure
2022-06-22 Injury None Adverse Event Without Identified Device or Use Problem
2022-06-14 Malfunction Appropriate Term / Code Not Available Electrical /Electronic Property Problem, Connection Problem, Intermittent Communication Failure
2022-03-31 Malfunction Appropriate Term / Code Not Available Adverse Event Without Identified Device or Use Problem, Therapeutic or Diagnostic Output Failure
2022-03-25 Injury Appropriate Term / Code Not Available Electrical /Electronic Property Problem, Misconnection, Electro-Static Discharge
2022-03-13 Injury None Adverse Event Without Identified Device or Use Problem, Output Problem
2022-03-08 Injury None Migration or Expulsion of Device, Expulsion
2022-03-07 Injury None Adverse Event Without Identified Device or Use Problem
2021-04-01 Injury Unspecified Infection, Swelling/ Edema Adverse Event Without Identified Device or Use Problem
2019-10-17 Injury None Device Dislodged or Dislocated
2019-10-10 Malfunction None Adverse Event Without Identified Device or Use Problem
2019-10-02 Malfunction None Appropriate Term/Code Not Available
2019-09-26 Malfunction None Appropriate Term/Code Not Available, Physical Resistance/Sticking
2019-09-24 Malfunction None Therapeutic or Diagnostic Output Failure, Appropriate Term/Code Not Available
2019-09-13 Malfunction None Adverse Event Without Identified Device or Use Problem
2019-09-12 Injury None Migration or Expulsion of Device
2019-09-04 Injury None Unintended Movement
2019-08-30 Injury None Adverse Event Without Identified Device or Use Problem
2019-08-28 Malfunction None Device Slipped
2019-08-28 Malfunction None Loose or Intermittent Connection, Appropriate Term/Code Not Available
2019-08-27 Malfunction None Structural Problem, Therapeutic or Diagnostic Output Failure
2019-08-26 Injury None Output Problem, Appropriate Term/Code Not Available
2019-08-26 Injury None Adverse Event Without Identified Device or Use Problem
2019-08-26 Malfunction None Adverse Event Without Identified Device or Use Problem
2019-08-20 Malfunction None Defective Device
2019-08-14 Injury None Device Dislodged or Dislocated
2019-08-12 Injury None Device Dislodged or Dislocated, Environmental Compatibility Problem
2019-08-09 Injury None Migration or Expulsion of Device
2019-08-07 Injury None Device Dislodged or Dislocated
2019-07-31 Injury None Adverse Event Without Identified Device or Use Problem
2019-07-26 Injury None Positioning Problem
2019-07-25 Injury None Migration or Expulsion of Device
2019-07-24 Malfunction None Output Problem
2019-07-24 Injury None Migration or Expulsion of Device
2019-07-21 Injury None Migration or Expulsion of Device, Expulsion, Adverse Event Without Identified Device or Use Problem
2019-07-19 Injury None Migration
2019-07-18 Malfunction None Therapeutic or Diagnostic Output Failure, Noise, Audible
2019-07-17 Injury None Adverse Event Without Identified Device or Use Problem
2019-07-16 Injury None Migration or Expulsion of Device
2019-07-12 Malfunction None Adverse Event Without Identified Device or Use Problem
2019-07-12 Malfunction None Therapeutic or Diagnostic Output Failure
2019-07-10 Malfunction None Therapeutic or Diagnostic Output Failure
2019-07-10 Malfunction None Output Problem
2019-07-08 Injury None Adverse Event Without Identified Device or Use Problem
2019-06-27 Injury None Material Protrusion/Extrusion
2019-06-27 Malfunction None Output Problem
2019-06-27 Malfunction None Therapeutic or Diagnostic Output Failure
2019-06-25 Injury None Migration
2019-06-25 Malfunction None Output Problem
2019-06-24 Injury None Migration or Expulsion of Device
2019-06-20 Injury None Migration or Expulsion of Device
2019-06-17 Injury None Adverse Event Without Identified Device or Use Problem
2019-06-17 Injury None Migration or Expulsion of Device, Output Problem, Appropriate Term/Code Not Available
2019-06-13 Injury None Migration or Expulsion of Device, Product Quality Problem, Output Problem
2019-06-13 Injury None Device Dislodged or Dislocated, Appropriate Term/Code Not Available
2019-06-11 Injury None Appropriate Term/Code Not Available
2019-06-10 Injury None Adverse Event Without Identified Device or Use Problem
2019-06-10 Injury None Device Dislodged or Dislocated
2019-06-10 Malfunction None Unexpected Therapeutic Results
2019-06-10 Malfunction None Patient-Device Incompatibility
2019-06-07 Malfunction None Mechanical Problem, Therapeutic or Diagnostic Output Failure, Intermittent Communication Failure
2019-06-06 Malfunction None Adverse Event Without Identified Device or Use Problem
2019-06-04 Injury None Microbial Contamination of Device, Material Protrusion/Extrusion
2019-06-03 Malfunction None Impedance Problem
2019-05-28 Injury None Break, Malposition of Device
2019-05-27 Injury None Appropriate Term/Code Not Available
2019-05-24 Injury None Material Protrusion/Extrusion
2019-05-23 Malfunction None Adverse Event Without Identified Device or Use Problem
2019-05-23 Injury None Adverse Event Without Identified Device or Use Problem
2019-05-22 Malfunction None Adverse Event Without Identified Device or Use Problem
2019-05-21 Malfunction None Therapeutic or Diagnostic Output Failure
2019-05-20 Malfunction None Unexpected Therapeutic Results
2019-05-17 Injury None Adverse Event Without Identified Device or Use Problem
2019-05-16 Injury None Migration or Expulsion of Device
2019-05-15 Malfunction None Malposition of Device
2019-05-15 Malfunction None Electro-Static Discharge, Therapeutic or Diagnostic Output Failure
2019-05-14 Injury None Adverse Event Without Identified Device or Use Problem
2019-05-14 Injury None Appropriate Term/Code Not Available
2019-05-13 Malfunction None Therapeutic or Diagnostic Output Failure
2019-05-09 Malfunction None Therapeutic or Diagnostic Output Failure
2019-05-09 Injury None Appropriate Term/Code Not Available
2019-05-08 Malfunction None Connection Problem
2019-05-06 Malfunction None Therapeutic or Diagnostic Output Failure
2019-05-01 Injury None Adverse Event Without Identified Device or Use Problem
2019-05-01 Injury None Adverse Event Without Identified Device or Use Problem
2019-05-01 Injury None Appropriate Term/Code Not Available
2019-05-01 Injury None Adverse Event Without Identified Device or Use Problem
2019-04-29 Injury None Program or Algorithm Execution Problem
2019-04-25 Injury None Adverse Event Without Identified Device or Use Problem
2019-04-24 Malfunction None Output Problem
2019-04-23 Injury None Improper or Incorrect Procedure or Method, Material Protrusion/Extrusion
2019-04-23 Malfunction None Therapeutic or Diagnostic Output Failure
2019-04-22 Injury None Adverse Event Without Identified Device or Use Problem
2019-04-21 Injury None Adverse Event Without Identified Device or Use Problem
2019-04-17 Injury None Adverse Event Without Identified Device or Use Problem
2019-04-17 Malfunction None Intermittent Continuity, Structural Problem
2019-04-17 Malfunction None Unexpected Therapeutic Results
2019-04-11 Injury None Unexpected Therapeutic Results
2019-04-05 Malfunction None Therapeutic or Diagnostic Output Failure
2019-04-04 Injury None Adverse Event Without Identified Device or Use Problem
2019-04-01 Injury None Output Problem
2019-04-01 Injury None Break, Therapeutic or Diagnostic Output Failure
2019-03-28 Injury None Migration
2019-03-28 Malfunction None Therapeutic or Diagnostic Output Failure
2019-03-26 Injury None Break, Device Dislodged or Dislocated
2019-03-25 Injury None Migration or Expulsion of Device, Appropriate Term/Code Not Available
2019-03-25 Injury None Migration
2019-03-22 Injury None Adverse Event Without Identified Device or Use Problem, Appropriate Term/Code Not Available
2019-03-22 Malfunction None Therapeutic or Diagnostic Output Failure
2019-03-20 Injury None Migration or Expulsion of Device
2019-03-17 Injury None Adverse Event Without Identified Device or Use Problem
2019-03-15 Injury None Material Protrusion/Extrusion
2019-03-14 Injury None Material Protrusion/Extrusion
2019-03-14 Malfunction None Output Problem
2019-03-13 Malfunction None Unexpected Therapeutic Results
2019-03-12 Injury None Patient-Device Incompatibility, Adverse Event Without Identified Device or Use Problem
2019-03-12 Malfunction None Unexpected Therapeutic Results
2019-03-08 Malfunction None Product Quality Problem
2019-03-08 Malfunction None Impedance Problem
2019-03-05 Injury None Positioning Problem
2019-03-01 Injury None Adverse Event Without Identified Device or Use Problem
2019-03-01 Injury None Adverse Event Without Identified Device or Use Problem
2019-02-28 Injury None Therapeutic or Diagnostic Output Failure
2019-02-28 Injury None Adverse Event Without Identified Device or Use Problem
2019-02-28 Malfunction None Therapeutic or Diagnostic Output Failure
2019-02-26 Injury None Adverse Event Without Identified Device or Use Problem
2019-02-26 Malfunction None Therapeutic or Diagnostic Output Failure
2019-02-25 Injury None Adverse Event Without Identified Device or Use Problem
2019-02-25 Malfunction None Therapeutic or Diagnostic Output Failure
2019-02-22 Injury None Adverse Event Without Identified Device or Use Problem
2019-02-21 Malfunction None Inappropriate Audible Prompt/Feedback, Therapeutic or Diagnostic Output Failure
2019-02-20 Injury None Adverse Event Without Identified Device or Use Problem
2019-02-20 Injury None Difficult to Insert, Positioning Problem
2019-02-19 Injury None Adverse Event Without Identified Device or Use Problem
2019-02-17 Injury None Appropriate Term/Code Not Available
2019-02-16 Injury None Adverse Event Without Identified Device or Use Problem, Appropriate Term/Code Not Available
2019-02-15 Injury None Appropriate Term/Code Not Available
2019-02-13 Injury None Migration or Expulsion of Device
2019-02-13 Malfunction None Output Problem
2019-02-06 Malfunction None Therapeutic or Diagnostic Output Failure
2019-02-06 Injury None Material Deformation
2019-02-05 Malfunction None Product Quality Problem
2019-02-05 Malfunction None Adverse Event Without Identified Device or Use Problem
2019-01-30 Injury None Positioning Problem
2019-01-28 Malfunction None Patient-Device Incompatibility
2019-01-26 Injury None Insufficient Information
2019-01-25 Injury None Adverse Event Without Identified Device or Use Problem
2019-01-23 Malfunction None Therapeutic or Diagnostic Output Failure
2019-01-22 Malfunction None Therapeutic or Diagnostic Output Failure
2019-01-21 Injury None Adverse Event Without Identified Device or Use Problem
2019-01-19 Injury None Appropriate Term/Code Not Available
2019-01-17 Malfunction None Therapeutic or Diagnostic Output Failure
2019-01-16 Malfunction None Output Problem
2019-01-12 Injury None Adverse Event Without Identified Device or Use Problem
2019-01-10 Injury None Adverse Event Without Identified Device or Use Problem
2019-01-08 Injury None Output below Specifications
2019-01-08 Injury None Therapeutic or Diagnostic Output Failure
2019-01-07 Malfunction None Intermittent Continuity
2019-01-03 Injury None Material Protrusion/Extrusion
2018-12-25 Injury None Insufficient Information
2018-12-21 Malfunction None Appropriate Term/Code Not Available
2018-12-20 Injury None Insufficient Information
2018-12-19 Malfunction None No Device Output
2018-12-18 Injury None Malposition of Device
2018-12-16 Injury None Adverse Event Without Identified Device or Use Problem
2018-12-12 Injury None Adverse Event Without Identified Device or Use Problem
2018-12-12 Injury None Intermittent Continuity
2018-12-10 Malfunction None Appropriate Term/Code Not Available
2018-12-07 Injury None Malposition of Device
2018-12-04 Malfunction None Adverse Event Without Identified Device or Use Problem
2018-11-30 Injury None Migration or Expulsion of Device
2018-11-29 Injury None Migration or Expulsion of Device, Output Problem
2018-11-28 Injury None Migration or Expulsion of Device
2018-11-24 Injury None Adverse Event Without Identified Device or Use Problem
2018-11-23 Injury None Migration or Expulsion of Device
2018-11-21 Malfunction None Adverse Event Without Identified Device or Use Problem
2018-11-20 Injury None Material Protrusion/Extrusion, Audible Prompt/Feedback Problem
2018-11-19 Malfunction None Appropriate Term/Code Not Available
2018-11-19 Injury None Migration
2018-11-17 Injury None Malposition of Device
2018-11-16 Injury None No Device Output
2018-11-14 Malfunction None Therapy Delivered to Incorrect Body Area
2018-11-13 Injury None Migration or Expulsion of Device
2018-11-12 Injury None Appropriate Term/Code Not Available
2018-11-09 Malfunction None Patient-Device Incompatibility, Appropriate Term/Code Not Available
2018-11-08 Injury None No Audible Prompt/Feedback
2018-11-06 Malfunction None Inaudible or Unclear Audible Prompt/Feedback
2018-11-05 Injury None Adverse Event Without Identified Device or Use Problem
2018-11-05 Malfunction None Audible Prompt/Feedback Problem
2018-10-31 Injury None Insufficient Information
2018-10-30 Injury None Material Protrusion/Extrusion
2018-10-29 Injury None Appropriate Term/Code Not Available
2018-10-24 Injury None Migration
2018-10-24 Malfunction None Device Operates Differently Than Expected
2018-10-22 Injury None Material Protrusion/Extrusion
2018-10-22 Malfunction None Loose or Intermittent Connection, Appropriate Term/Code Not Available
2018-10-21 Malfunction None No Device Output
2018-10-20 Injury None Material Protrusion/Extrusion
2018-10-19 Injury None Product Quality Problem
2018-10-19 Injury None Insufficient Information
2018-10-17 Injury None Material Protrusion/Extrusion
2018-10-14 Injury None Adverse Event Without Identified Device or Use Problem
2018-10-11 Injury None Migration or Expulsion of Device, Material Deformation
2018-10-10 Malfunction None No Device Output
2018-10-08 Injury None Material Protrusion/Extrusion
2018-10-05 Injury None Migration or Expulsion of Device
2018-10-04 Injury None Migration or Expulsion of Device
2018-10-04 Injury None No Device Output
2018-10-02 Injury None Material Protrusion/Extrusion
2018-09-28 Injury None Migration or Expulsion of Device, Appropriate Term/Code Not Available
2018-09-27 Injury None Adverse Event Without Identified Device or Use Problem
2018-09-27 Malfunction None Defective Device
2018-09-24 Injury None Migration or Expulsion of Device, No Device Output
2018-09-20 Injury None Material Protrusion/Extrusion
2018-09-19 Injury None Migration or Expulsion of Device, Appropriate Term/Code Not Available
2018-09-19 Malfunction None Insufficient Information
2018-09-18 Injury None Migration or Expulsion of Device
2018-09-18 Malfunction None Loose or Intermittent Connection
2018-09-17 Injury None Device Dislodged or Dislocated
2018-09-17 Injury None Adverse Event Without Identified Device or Use Problem
2018-09-17 Injury None Positioning Problem
2018-09-11 Malfunction None Insufficient Information
2018-09-11 Injury None Material Protrusion/Extrusion
2018-09-06 Injury None Unexpected Therapeutic Results
2018-09-06 Injury None Adverse Event Without Identified Device or Use Problem
2018-09-04 Injury None Material Protrusion/Extrusion
2018-09-03 Injury None Adverse Event Without Identified Device or Use Problem
2018-09-03 Injury None Insufficient Information
2018-09-02 Injury None Appropriate Term/Code Not Available
2018-08-31 Injury None Migration or Expulsion of Device
2018-08-25 Injury None Insufficient Information
2018-08-24 Injury None Adverse Event Without Identified Device or Use Problem
2018-08-24 Injury None Material Protrusion/Extrusion
2018-08-23 Malfunction None Insufficient Information
2018-08-20 Malfunction None Defective Device
2018-08-15 Injury None Migration or Expulsion of Device
2018-08-13 Malfunction None Insufficient Information
2018-08-10 Injury None Insufficient Information
2018-08-09 Injury None Insufficient Information
2018-08-08 Malfunction None Loose or Intermittent Connection
2018-08-08 Injury None Material Protrusion/Extrusion
2018-08-07 Injury None Appropriate Term/Code Not Available
2018-08-01 Injury None Device-Device Incompatibility, Unintended Movement
2018-07-30 Malfunction None Output below Specifications
2018-07-25 Injury None Adverse Event Without Identified Device or Use Problem
2018-07-22 Injury None Appropriate Term/Code Not Available
2018-07-19 Injury None Material Protrusion/Extrusion
2018-07-19 Injury None Migration or Expulsion of Device
2018-07-18 Injury None Adverse Event Without Identified Device or Use Problem
2018-07-11 Malfunction None Electromagnetic Interference, Device Sensing Problem, Naturally Worn
2018-07-11 Injury None Appropriate Term/Code Not Available
2018-07-09 Injury None Adverse Event Without Identified Device or Use Problem
2018-07-03 Malfunction None Device Stops Intermittently, Defective Device
2018-07-01 Injury None Material Protrusion/Extrusion
2018-06-29 Injury None Migration or Expulsion of Device, Material Protrusion/Extrusion
2018-06-29 Injury None Migration or Expulsion of Device, Material Protrusion/Extrusion
2018-06-26 Injury None Material Protrusion/Extrusion
2018-06-26 Malfunction None Loose or Intermittent Connection
2018-06-25 Malfunction None Defective Device
2018-06-23 Injury None Adverse Event Without Identified Device or Use Problem
2018-06-22 Malfunction None Loose or Intermittent Connection
2018-06-21 Injury None Material Protrusion/Extrusion
2018-06-19 Injury None Insufficient Information
2018-06-18 Injury None Appropriate Term/Code Not Available
2018-06-14 Malfunction None Computer Software Problem
2018-06-08 Injury None Migration or Expulsion of Device
2018-06-06 Injury None Contamination, Migration or Expulsion of Device
2018-06-06 Injury None Insufficient Information
2018-06-04 Injury None Adverse Event Without Identified Device or Use Problem
2018-06-04 Injury None Extrusion
2018-05-29 Malfunction None Improper or Incorrect Procedure or Method
2018-05-28 Malfunction None Adverse Event Without Identified Device or Use Problem
2018-05-28 Injury None Migration or Expulsion of Device
2018-05-25 Injury None Positioning Problem
2018-05-22 Malfunction None Device Operates Differently Than Expected
2018-05-22 Injury None Adverse Event Without Identified Device or Use Problem
2018-05-18 Injury None Migration or Expulsion of Device
2018-05-16 Malfunction None Adverse Event Without Identified Device or Use Problem
2018-05-15 Injury None Migration or Expulsion of Device
2018-05-14 Malfunction None Device Packaging Compromised
2018-05-11 Injury None Extrusion
2018-05-04 Injury None Adverse Event Without Identified Device or Use Problem
2018-05-01 Injury None Device Dislodged or Dislocated
2018-05-01 Injury None Adverse Event Without Identified Device or Use Problem
2018-05-01 Injury None Material Protrusion/Extrusion
2018-04-30 Injury None Extrusion
2018-04-24 Injury None Adverse Event Without Identified Device or Use Problem
2018-04-23 Injury None Insufficient Information
2018-04-23 Malfunction None Device Operates Differently Than Expected, Output below Specifications
2018-04-23 Injury None Insufficient Information
2018-04-20 Injury None Appropriate Term/Code Not Available
2018-04-19 Injury None Adverse Event Without Identified Device or Use Problem
2018-04-17 Malfunction None Device Operates Differently Than Expected
2018-04-09 Malfunction None Device Operates Differently Than Expected
2018-04-03 Injury None Extrusion
2018-04-03 Injury None Material Protrusion/Extrusion
2018-04-03 Malfunction None Insufficient Information
2018-04-02 Injury None Migration or Expulsion of Device
2018-04-01 Injury None Extrusion
2018-04-01 Injury None Extrusion
2018-04-01 Injury None Extrusion
2018-03-30 Injury None Adverse Event Without Identified Device or Use Problem
2018-03-26 Injury None Extrusion
2018-03-23 Malfunction None Device Operates Differently Than Expected
2018-03-22 Injury None Insufficient Information
2018-03-22 Injury None Patient-Device Incompatibility
2018-03-19 Malfunction None Appropriate Term/Code Not Available
2018-03-16 Injury None Adverse Event Without Identified Device or Use Problem
2018-03-16 Injury None Migration or Expulsion of Device
2018-03-15 Injury None Adverse Event Without Identified Device or Use Problem
2018-03-15 Injury None Break
2018-03-15 Malfunction None Device Operates Differently Than Expected
2018-03-11 Malfunction None Loose or Intermittent Connection
2018-03-10 Malfunction None Pacing Problem
2018-03-05 Malfunction None Device Operates Differently Than Expected
2018-03-05 Injury None Adverse Event Without Identified Device or Use Problem
2018-03-02 Injury None Insufficient Information
2018-03-01 Injury None Adverse Event Without Identified Device or Use Problem
2018-03-01 Malfunction None Device Operates Differently Than Expected
2018-03-01 Injury None Extrusion
2018-02-26 Injury None Adverse Event Without Identified Device or Use Problem
2018-02-26 Injury None Material Protrusion/Extrusion
2018-02-23 Injury None Migration or Expulsion of Device, Programming Issue
2018-02-22 Injury None Migration or Expulsion of Device
2018-02-21 Injury None Appropriate Term/Code Not Available
2018-02-18 Injury None Adverse Event Without Identified Device or Use Problem
2018-02-15 Malfunction None Device Operates Differently Than Expected
2018-02-15 Malfunction None Adverse Event Without Identified Device or Use Problem
2018-02-13 Malfunction None Insufficient Information
2018-02-12 Malfunction None Device Operates Differently Than Expected
2018-02-09 Malfunction None Device Operates Differently Than Expected
2018-02-08 Injury None Adverse Event Without Identified Device or Use Problem
2018-02-07 Injury None Migration or Expulsion of Device
2018-02-06 Injury None Adverse Event Without Identified Device or Use Problem
2018-02-06 Injury None Device Emits Odor
2018-02-06 Malfunction None Device Operates Differently Than Expected
2018-02-05 Malfunction None Device Operates Differently Than Expected
2018-02-01 Injury None Adverse Event Without Identified Device or Use Problem
2018-01-26 Injury None Insufficient Information
2018-01-25 Injury None Adverse Event Without Identified Device or Use Problem
2018-01-25 Injury None Migration or Expulsion of Device
2018-01-24 Malfunction None Device Inoperable
2018-01-22 Injury None Material Protrusion/Extrusion
2018-01-19 Injury None Appropriate Term/Code Not Available
2018-01-19 Injury None Device Operates Differently Than Expected
2018-01-19 Injury None Extrusion
2018-01-18 Injury None Insufficient Information
2018-01-17 Injury None Extrusion
2018-01-17 Injury None Device Operates Differently Than Expected
2018-01-16 Malfunction None Device Operates Differently Than Expected
2018-01-16 Malfunction None Device Operates Differently Than Expected
2018-01-15 Malfunction None Insufficient Information
2018-01-10 Injury None Material Protrusion/Extrusion
2018-01-05 Injury None Insufficient Information
2018-01-05 Malfunction None Programming Issue
2018-01-05 Injury None Appropriate Term/Code Not Available
2018-01-04 Injury None Material Protrusion/Extrusion
2018-01-01 Injury None Adverse Event Without Identified Device or Use Problem
2018-01-01 Injury None Expulsion
2017-12-28 Injury None Insufficient Information
2017-12-20 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-19 Injury None Positioning Problem
2017-12-19 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-18 Injury None Migration or Expulsion of Device
2017-12-14 Injury None Device Dislodged or Dislocated
2017-12-13 Injury None Insufficient Information
2017-12-07 Injury None Insufficient Information
2017-12-07 Injury None Insufficient Information
2017-12-05 Malfunction None Device Inoperable
2017-12-05 Injury None Insufficient Information
2017-12-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-04 Injury None Positioning Problem
2017-12-01 Injury None Extrusion
2017-12-01 Malfunction None Device Operates Differently Than Expected
2017-12-01 Injury None Migration or Expulsion of Device
2017-11-27 Injury None Migration or Expulsion of Device
2017-11-24 Injury None Insufficient Information
2017-11-24 Injury None Adverse Event Without Identified Device or Use Problem
2017-11-20 Injury None Device Dislodged or Dislocated
2017-11-20 Injury None Malposition of Device
2017-11-17 Injury None Extrusion
2017-11-16 Injury None Malposition of Device
2017-11-15 Injury None Migration or Expulsion of Device
2017-11-15 Malfunction None Insufficient Information
2017-11-15 Injury None Electromagnetic Interference, Improper or Incorrect Procedure or Method
2017-11-15 Malfunction None Product Quality Problem, Device Inoperable
2017-11-14 Malfunction None Device Operates Differently Than Expected
2017-11-13 Injury None Positioning Problem
2017-11-13 Malfunction None Device Inoperable
2017-11-13 Malfunction None Device Operates Differently Than Expected
2017-11-11 Injury None Migration or Expulsion of Device
2017-11-10 Injury None Malposition of Device
2017-11-08 Malfunction None Device Operates Differently Than Expected
2017-11-07 Injury None Appropriate Term/Code Not Available
2017-11-01 Injury None Device Operates Differently Than Expected
2017-11-01 Injury None Malposition of Device
2017-10-30 Injury None Extrusion
2017-10-27 Injury None Adverse Event Without Identified Device or Use Problem
2017-10-26 Injury None Insufficient Information
2017-10-25 Injury None Adverse Event Without Identified Device or Use Problem
2017-10-25 Injury None Insufficient Information
2017-10-24 Malfunction None Device Inoperable
2017-10-24 Malfunction None Device Inoperable
2017-10-23 Injury None Migration or Expulsion of Device
2017-10-23 Injury None Insufficient Information
2017-10-20 Injury None Insufficient Information
2017-10-20 Injury None Material Protrusion/Extrusion
2017-10-18 Malfunction None Device Operates Differently Than Expected
2017-10-18 Injury None Migration or Expulsion of Device
2017-10-12 Injury None Insufficient Information
2017-10-12 Injury None Adverse Event Without Identified Device or Use Problem
2017-10-11 Injury None Insufficient Information
2017-10-11 Injury None Positioning Problem
2017-10-11 Malfunction None Insufficient Information
2017-10-10 Malfunction None Device Operates Differently Than Expected
2017-10-05 Injury None Device Operates Differently Than Expected
2017-10-05 Injury None Insufficient Information
2017-10-05 Injury None Device Stops Intermittently
2017-10-04 Injury None Adverse Event Without Identified Device or Use Problem
2017-10-01 Injury None Patient-Device Incompatibility
2017-10-01 Injury None Insufficient Information
2017-09-29 Injury None Adverse Event Without Identified Device or Use Problem
2017-09-28 Injury None Insufficient Information
2017-09-25 Malfunction None Product Quality Problem
2017-09-25 Injury None Insufficient Information
2017-09-21 Injury None Adverse Event Without Identified Device or Use Problem
2017-09-21 Injury None Adverse Event Without Identified Device or Use Problem
2017-09-21 Injury None Appropriate Term/Code Not Available
2017-09-18 Malfunction None Defibrillation/Stimulation Problem
2017-09-13 Injury None Device Operates Differently Than Expected
2017-09-12 Injury None Extrusion
2017-09-06 Injury None Device Dislodged or Dislocated
2017-09-06 Injury None Adverse Event Without Identified Device or Use Problem
2017-09-05 Injury None Tear, Rip or Hole in Device Packaging
2017-08-24 Injury None Device Operates Differently Than Expected
2017-08-24 Injury None Extrusion
2017-08-22 Injury None Appropriate Term/Code Not Available
2017-08-18 Injury None Insufficient Information
2017-08-17 Injury None Positioning Problem
2017-08-16 Injury None Insufficient Information
2017-08-10 Injury None Insufficient Information
2017-08-08 Injury None Device Operates Differently Than Expected
2017-08-08 Malfunction None Device Operates Differently Than Expected, Programming Issue
2017-08-08 Injury None Migration or Expulsion of Device
2017-08-06 Injury None Device Operates Differently Than Expected
2017-08-04 Injury None Insufficient Information
2017-08-04 Injury None Insufficient Information
2017-08-02 Injury None Extrusion
2017-08-02 Malfunction None Device Operates Differently Than Expected
2017-08-01 Injury None Device Operates Differently Than Expected
2017-08-01 Injury None Extrusion
2017-08-01 Injury None Insufficient Information
2017-07-31 Malfunction None Device Stops Intermittently
2017-07-28 Malfunction None Device Operates Differently Than Expected
2017-07-27 Injury None Insufficient Information
2017-07-24 Malfunction None Device Slipped
2017-07-20 Injury None Extrusion
2017-07-20 Injury None Adverse Event Without Identified Device or Use Problem
2017-07-20 Injury None Migration or Expulsion of Device
2017-07-19 Injury None Insufficient Information
2017-07-18 Injury None Positioning Problem
2017-07-18 Injury None Device Stops Intermittently
2017-07-18 Malfunction None Insufficient Information
2017-07-17 Injury None Insufficient Information
2017-07-14 Injury None Insufficient Information
2017-07-13 Malfunction None Loose or Intermittent Connection
2017-07-11 Malfunction None Device Operates Differently Than Expected
2017-07-11 Malfunction None Device Inoperable, Programming Issue
2017-07-11 Injury None Migration or Expulsion of Device
2017-07-10 Injury None Device Operates Differently Than Expected
2017-07-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-07-09 Injury None Adverse Event Without Identified Device or Use Problem
2017-07-05 Injury None Insufficient Information
2017-07-05 Malfunction None Adverse Event Without Identified Device or Use Problem
2017-07-03 Injury None Device Operates Differently Than Expected, Positioning Problem
2017-07-01 Injury None Adverse Event Without Identified Device or Use Problem, Appropriate Term/Code Not Available
2017-07-01 Injury None Adverse Event Without Identified Device or Use Problem
2017-06-30 Injury None Migration or Expulsion of Device
2017-06-30 Injury None Insufficient Information
2017-06-30 Injury None Extrusion
2017-06-30 Injury None Migration or Expulsion of Device
2017-06-29 Injury None Migration or Expulsion of Device
2017-06-29 Injury None Extrusion
2017-06-29 Injury None Unintended Movement
2017-06-25 Injury None Extrusion
2017-06-25 Injury None Insufficient Information
2017-06-23 Injury None Insufficient Information
2017-06-22 Injury None Device Dislodged or Dislocated
2017-06-15 Injury None Migration or Expulsion of Device
2017-06-15 Injury None Positioning Problem
2017-06-13 Injury None Migration or Expulsion of Device
2017-06-13 Injury None Device Operates Differently Than Expected
2017-06-09 Injury None Material Protrusion/Extrusion
2017-06-06 Injury None Folded
2017-06-06 Injury None Patient-Device Incompatibility
2017-06-06 Injury None Insufficient Information
2017-06-05 Injury None Positioning Problem
2017-06-02 Injury None Migration or Expulsion of Device
2017-05-31 Malfunction None Device Operates Differently Than Expected
2017-05-31 Injury None Positioning Problem
2017-05-30 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-29 Injury None Extrusion
2017-05-26 Injury None Device Operates Differently Than Expected
2017-05-25 Injury None Programming Issue
2017-05-23 Injury None Extrusion
2017-05-22 Injury None Migration or Expulsion of Device
2017-05-20 Injury None Extrusion
2017-05-19 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-14 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-12 Malfunction None Product Quality Problem, Material Protrusion/Extrusion
2017-05-09 Malfunction None Device Operates Differently Than Expected
2017-05-03 Malfunction None Device Inoperable, Programming Issue
2017-05-02 Injury None Programming Issue
2017-05-01 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-28 Injury None Migration or Expulsion of Device
2017-04-28 Injury None Extrusion
2017-04-27 Injury None Migration or Expulsion of Device
2017-04-27 Injury None Insufficient Information
2017-04-26 Injury None Device Operates Differently Than Expected
2017-04-25 Injury None Extrusion
2017-04-24 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-24 Injury None Migration
2017-04-24 Injury None Extrusion
2017-04-24 Malfunction None No Device Output
2017-04-22 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-18 Injury None Impedance Problem
2017-04-18 Injury None Patient-Device Incompatibility
2017-04-17 Injury None Device Inoperable
2017-04-14 Malfunction None Device Operates Differently Than Expected
2017-04-13 Injury None Electromagnetic Interference
2017-04-12 Injury None Positioning Problem
2017-04-11 Injury None Extrusion
2017-04-11 Injury None Extrusion
2017-04-10 Injury None Migration or Expulsion of Device
2017-04-07 Injury None Migration or Expulsion of Device
2017-04-07 Injury None Difficult to Insert, Positioning Problem
2017-04-06 Injury None Difficult to Insert
2017-04-05 Injury None Migration or Expulsion of Device
2017-04-04 Injury None Insufficient Information
2017-04-03 Malfunction None Device Slipped, Device Stops Intermittently
2017-03-29 Injury None Migration or Expulsion of Device
2017-03-27 Malfunction None Positioning Problem
2017-03-27 Injury None Programming Issue
2017-03-26 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-24 Injury None Insufficient Information
2017-03-23 Malfunction None Device Slipped
2017-03-21 Injury None Insufficient Information
2017-03-19 Injury None Insufficient Information
2017-03-17 Injury None Extrusion
2017-03-17 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-17 Injury None Positioning Problem
2017-03-16 Malfunction None Device Dislodged or Dislocated
2017-03-16 Injury None Insufficient Information
2017-03-16 Injury None Insufficient Information
2017-03-11 Injury None Insufficient Information
2017-03-09 Injury None Device Operates Differently Than Expected
2017-03-09 Injury None Migration or Expulsion of Device, Programming Issue
2017-03-06 Injury None Extrusion
2017-03-04 Malfunction None Device Slipped, Device Stops Intermittently
2017-03-03 Injury None Insufficient Information
2017-03-01 Injury None Material Protrusion/Extrusion
2017-02-28 Injury None Insufficient Information
2017-02-28 Malfunction None Insufficient Information
2017-02-27 Injury None Product Quality Problem, Programming Issue
2017-02-27 Malfunction None Device Slipped
2017-02-24 Injury None Appropriate Term/Code Not Available
2017-02-22 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-21 Injury None Migration or Expulsion of Device
2017-02-21 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-18 Injury None Insufficient Information
2017-02-18 Injury None Insufficient Information
2017-02-16 Injury None Insufficient Information
2017-02-09 Injury None Insufficient Information
2017-02-08 Malfunction None Insufficient Information
2017-02-08 Injury None Patient-Device Incompatibility
2017-02-07 Injury None Cut In Material
2017-02-02 Injury None Positioning Problem
2017-02-02 Injury None Insufficient Information
2017-02-01 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-01 Malfunction None Patient-Device Incompatibility, Device Operates Differently Than Expected
2017-01-27 Injury None Insufficient Information
2017-01-25 Injury None Insufficient Information
2017-01-25 Injury None Malposition of Device
2017-01-24 Injury None Insufficient Information
2017-01-24 Injury None Device Stops Intermittently, Programming Issue
2017-01-19 Injury None Insufficient Information
2017-01-16 Injury None Insufficient Information
2017-01-12 Injury None Insufficient Information
2017-01-11 Malfunction None Insufficient Information
2017-01-11 Injury None Migration or Expulsion of Device
2017-01-11 Malfunction None Noise, Audible
2017-01-10 Malfunction None Device Slipped
2017-01-10 Injury None Migration or Expulsion of Device
2017-01-10 Injury None Patient-Device Incompatibility
2017-01-09 Injury None Extrusion
2017-01-06 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-04 Malfunction None Device Slipped
2017-01-04 Injury None Migration or Expulsion of Device
2017-01-01 Injury None Extrusion
2017-01-01 Injury None Insufficient Information
2016-12-30 Injury None Extrusion
2016-12-30 Malfunction None Device Operates Differently Than Expected
2016-12-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-29 Injury None Extrusion
2016-12-27 Injury None Insufficient Information
2016-12-27 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-22 Malfunction None Device Operates Differently Than Expected
2016-12-22 Injury None Insufficient Information
2016-12-20 Injury None Extrusion
2016-12-15 Injury None Difficult To Position, Improper or Incorrect Procedure or Method, Physical Property Issue
2016-12-14 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-14 Injury None Impedance Problem
2016-12-11 Injury None Migration or Expulsion of Device
2016-12-09 Injury None Appropriate Term/Code Not Available
2016-12-07 Injury None Extrusion
2016-12-01 Injury None Insufficient Information
2016-12-01 Injury None Extrusion
2016-12-01 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-01 Injury None Migration or Expulsion of Device
2016-12-01 Injury None Insufficient Information
2016-11-28 Malfunction None Appropriate Term/Code Not Available
2016-11-23 Injury None Patient-Device Incompatibility
2016-11-22 Injury None Patient-Device Incompatibility
2016-11-21 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-21 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-18 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-18 Injury None Insufficient Information
2016-11-17 Injury None Insufficient Information
2016-11-17 Malfunction None Device Slipped
2016-11-17 Malfunction None Circuit Failure
2016-11-17 Injury None Migration or Expulsion of Device, No Device Output
2016-11-17 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-15 Injury None Electromagnetic Interference
2016-11-15 Injury None Programming Issue
2016-11-13 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-11 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-10 Injury None Insufficient Information
2016-11-09 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-04 Injury None Extrusion
2016-11-04 Injury None Insufficient Information
2016-11-01 Injury None Contamination of Device Ingredient or Reagent
2016-10-28 Injury None Device Operates Differently Than Expected
2016-10-24 Injury None Migration or Expulsion of Device
2016-10-21 Injury None Impedance Problem
2016-10-19 Injury None Difficult to Insert
2016-10-19 Injury None Migration or Expulsion of Device, Extrusion
2016-10-14 Injury None Insufficient Information
2016-10-12 Malfunction None Device Inoperable
2016-10-12 Injury None Device Operates Differently Than Expected
2016-10-11 Injury None Insufficient Information
2016-10-09 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-08 Injury None Difficult to Insert
2016-10-07 Injury None Extrusion
2016-10-07 Malfunction None Adverse Event Without Identified Device or Use Problem
2016-10-04 Injury None Malposition of Device
2016-10-04 Malfunction None Device Operates Differently Than Expected
2016-10-01 Injury None Migration or Expulsion of Device
2016-09-30 Injury None Insufficient Information
2016-09-25 Injury None Device Operates Differently Than Expected
2016-09-24 Injury None Insufficient Information
2016-09-22 Injury None Insufficient Information
2016-09-21 Malfunction None Device Slipped
2016-09-20 Injury None Adverse Event Without Identified Device or Use Problem
2016-09-20 Injury None Device Dislodged or Dislocated
2016-09-19 Injury None Insufficient Information
2016-09-19 Injury None Insufficient Information
2016-09-19 Injury None Insufficient Information
2016-09-17 Injury None Insufficient Information
2016-09-16 Injury None Adverse Event Without Identified Device or Use Problem
2016-09-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-09-13 Injury None Extrusion
2016-09-10 Injury None Insufficient Information
2016-09-08 Injury None Device Operates Differently Than Expected
2016-09-07 Injury None Material Protrusion/Extrusion, Migration
2016-09-07 Malfunction None Mechanical Problem
2016-09-06 Injury None Material Protrusion/Extrusion
2016-09-06 Injury None Adverse Event Without Identified Device or Use Problem
2016-09-06 Injury None Migration or Expulsion of Device
2016-09-02 Injury None Adverse Event Without Identified Device or Use Problem
2016-08-31 Malfunction None Mechanical Problem
2016-08-28 Malfunction None Device Slipped
2016-08-24 Injury None Extrusion
2016-08-22 Injury None Insufficient Information
2016-08-22 Injury None Insufficient Information
2016-08-20 Injury None Extrusion
2016-08-20 Injury None Extrusion
2016-08-16 Injury None Insufficient Information
2016-08-15 Injury None Insufficient Information
2016-08-12 Malfunction None Programming Issue
2016-08-11 Injury None Insufficient Information
2016-08-11 Injury None Migration or Expulsion of Device
2016-08-09 Injury None Insufficient Information
2016-08-09 Injury None Insufficient Information
2016-08-08 Injury None Extrusion
2016-08-08 Injury None Insufficient Information
2016-08-02 Injury None Extrusion
2016-08-01 Injury None Appropriate Term/Code Not Available
2016-07-22 Injury None Adverse Event Without Identified Device or Use Problem
2016-07-22 Injury None Migration or Expulsion of Device
2016-07-21 Injury None Malposition of Device
2016-07-21 Injury None Extrusion
2016-07-21 Malfunction None Device Slipped
2016-07-19 Injury None Adverse Event Without Identified Device or Use Problem
2016-07-16 Injury None Extrusion
2016-07-14 Injury None Migration or Expulsion of Device
2016-07-14 Injury None Insufficient Information
2016-07-13 Injury None Malposition of Device
2016-07-13 Injury None Migration or Expulsion of Device
2016-07-08 Injury None Adverse Event Without Identified Device or Use Problem
2016-07-04 Injury None Insufficient Information
2016-07-01 Injury None Insufficient Information
2016-06-24 Injury None Insufficient Information
2016-06-23 Injury None Device Operates Differently Than Expected
2016-06-22 Injury None Appropriate Term/Code Not Available
2016-06-15 Injury None Insufficient Information
2016-06-15 Injury None Migration or Expulsion of Device
2016-06-07 Injury None Insufficient Information
2016-06-01 Injury None Appropriate Term/Code Not Available
2016-06-01 Injury None Insufficient Information
2016-06-01 Injury None Adverse Event Without Identified Device or Use Problem
2016-05-01 Injury None Adverse Event Without Identified Device or Use Problem
2016-04-11 Injury None Insufficient Information
2016-04-01 Injury None Migration or Expulsion of Device
2016-03-08 Injury None Insufficient Information
2016-03-02 Injury None Migration or Expulsion of Device
2016-03-01 Injury None Insufficient Information
2016-02-29 Injury None Insufficient Information
2016-02-15 Injury None Appropriate Term/Code Not Available
2016-02-09 Injury None Insufficient Information
2016-02-01 Injury None Insufficient Information
2016-01-05 Injury None Insufficient Information
2016-01-01 Injury None Appropriate Term/Code Not Available
2016-01-01 Injury None Adverse Event Without Identified Device or Use Problem
2015-12-23 Injury None Adverse Event Without Identified Device or Use Problem
2015-12-08 Injury None Migration or Expulsion of Device
2015-11-19 Injury None Insufficient Information
2015-10-19 Injury None Adverse Event Without Identified Device or Use Problem
2015-10-05 Injury None Device Stops Intermittently
2015-09-30 Injury None Insufficient Information
2015-09-27 Injury None Insufficient Information
2015-08-17 Injury None Migration or Expulsion of Device
2015-08-06 Injury None Device Operates Differently Than Expected
2015-06-01 Injury None Patient-Device Incompatibility
2015-05-27 Injury None Migration or Expulsion of Device
2015-05-15 Injury None Migration or Expulsion of Device
2015-05-13 Injury None Adverse Event Without Identified Device or Use Problem
2015-05-13 Injury None Migration or Expulsion of Device
2015-05-06 Injury None Communication or Transmission Problem, Device Operates Differently Than Expected
2015-05-06 Malfunction None Device Slipped
2015-05-04 Malfunction None No Device Output
2015-05-01 Injury None Migration or Expulsion of Device
2015-04-30 Malfunction None Device Operates Differently Than Expected
2015-04-29 Injury None Migration or Expulsion of Device
2015-04-28 Injury None Insufficient Information
2015-04-27 Injury None Device Operates Differently Than Expected
2015-04-24 Injury None Malposition of Device
2015-04-22 Injury None Material Protrusion/Extrusion
2015-04-21 Injury None Insufficient Information
2015-04-17 Injury None Migration or Expulsion of Device
2015-04-10 Injury None Insufficient Information
2015-04-10 Injury None Insufficient Information
2015-04-10 Injury None Insufficient Information
2015-04-07 Injury None Device Operates Differently Than Expected
2015-04-07 Malfunction None No Device Output
2015-04-01 Injury None Device Operates Differently Than Expected, Extrusion
2015-03-31 Malfunction None Device Operates Differently Than Expected
2015-03-31 Injury None No Device Output
2015-03-30 Injury None Device Operates Differently Than Expected
2015-03-27 Injury None Break, Positioning Problem
2015-03-19 Injury None Adverse Event Without Identified Device or Use Problem
2015-03-17 Injury None Leak/Splash
2015-03-17 Injury None Adverse Event Without Identified Device or Use Problem
2015-03-11 Injury None Insufficient Information
2015-03-01 Injury None Insufficient Information
2015-02-23 Injury None Insufficient Information
2015-02-11 Injury None Insufficient Information
2015-02-09 Injury None Insufficient Information
2015-01-22 Injury None Insufficient Information
2015-01-01 Injury None Insufficient Information
2014-12-14 Injury None Insufficient Information
2014-07-02 Injury None Insufficient Information
2014-07-02 Injury None Insufficient Information
2014-06-26 Injury None Device Operates Differently Than Expected, Positioning Problem
2014-06-26 Injury None Insufficient Information
2014-06-24 Injury None Insufficient Information
2014-06-23 Injury None Insufficient Information
2014-06-20 Injury None Improper or Incorrect Procedure or Method
2014-06-16 Injury None Migration or Expulsion of Device
2014-06-06 Injury None Therapeutic or Diagnostic Output Failure
2014-06-04 Injury None Insufficient Information
2014-06-02 Injury None Insufficient Information
2014-05-30 Injury None Migration or Expulsion of Device
2014-05-29 Injury None Insufficient Information
2014-05-29 Malfunction None No Device Output
2014-05-23 Injury None Insufficient Information
2014-05-19 Injury None Insufficient Information
2014-05-17 Injury None Extrusion
2014-05-16 Injury None Insufficient Information
2014-05-15 Malfunction None Appropriate Term/Code Not Available
2014-05-15 Injury None No Device Output
2014-05-14 Injury None Extrusion
2014-05-09 Injury None Patient-Device Incompatibility
2014-05-09 Injury None Insufficient Information
2014-05-05 Malfunction None Programming Issue
2014-04-29 Injury None Appropriate Term/Code Not Available
2014-04-28 Injury None Insufficient Information
2014-04-28 Injury None Insufficient Information
2014-04-22 Injury None Device Operates Differently Than Expected
2014-04-17 Injury None Migration or Expulsion of Device
2014-04-11 Injury None Device Operates Differently Than Expected
2014-04-11 Malfunction None Connection Problem
2014-04-10 Injury None Device Operates Differently Than Expected
2014-04-10 Injury None Extrusion
2014-04-09 Malfunction None Difficult to Remove
2014-04-08 Malfunction None Device Inoperable
2014-04-04 Injury None Extrusion
2014-04-03 Injury None Device Operates Differently Than Expected, Device Dislodged or Dislocated
2014-03-31 Injury None Break
2014-03-26 Malfunction None No Device Output
2014-03-25 Injury None Positioning Problem
2014-03-25 Injury None Folded
2014-03-24 Injury None Insufficient Information
2014-03-20 Injury None Adverse Event Without Identified Device or Use Problem
2014-03-18 Injury None Device Operates Differently Than Expected
2014-03-15 Injury None Patient-Device Incompatibility, Device Operates Differently Than Expected
2014-03-14 Injury None Insufficient Information
2014-03-11 Injury None False Device Output
2014-03-11 Injury None Scratched Material
2014-02-27 Injury None Device Operates Differently Than Expected
2014-02-26 Injury None Insufficient Information
2014-02-26 Injury None Patient-Device Incompatibility
2014-02-26 Injury None Device Operates Differently Than Expected, Positioning Problem
2014-02-25 Malfunction None No Device Output
2014-02-24 Injury None Insufficient Information
2014-02-21 Injury None Insufficient Information
2014-02-20 Injury None Insufficient Information
2014-02-17 Injury None Extrusion
2014-02-13 Injury None No Device Output
2014-02-10 Injury None Insufficient Information
2014-02-10 Injury None Migration or Expulsion of Device, Material Protrusion/Extrusion
2014-02-06 Injury None Device Operates Differently Than Expected
2014-02-04 Injury None Insufficient Information
2014-02-04 Injury None Patient-Device Incompatibility
2014-02-03 Injury None Device Operates Differently Than Expected, Material Integrity Problem
2014-02-01 Injury None Insufficient Information
2014-01-28 Injury None Insufficient Information
2014-01-22 Injury None Migration or Expulsion of Device
2014-01-22 Injury None Device Stops Intermittently, Device Inoperable
2014-01-17 Injury None Insufficient Information
2014-01-16 Injury None Insufficient Information
2014-01-14 Injury None Device Operates Differently Than Expected
2014-01-13 Injury None Appropriate Term/Code Not Available
2014-01-10 Injury None Positioning Problem
2014-01-10 Injury None Folded, Positioning Problem
2014-01-09 Injury None Insufficient Information
2014-01-06 Injury None Migration or Expulsion of Device
2014-01-01 Injury None Insufficient Information
2013-12-30 Injury None Extrusion
2013-12-20 Injury None Insufficient Information
2013-12-19 Injury None Adverse Event Without Identified Device or Use Problem
2013-12-16 Injury None Insufficient Information
2013-12-16 Injury None Device Operates Differently Than Expected, Programming Issue
2013-12-11 Injury None Insufficient Information
2013-12-09 Injury None None
2013-12-05 Injury None None
2013-12-01 Injury None None
2013-11-29 Injury None Extrusion
2013-11-29 Injury None Insufficient Information
2013-11-22 Injury None None
2013-11-19 Injury None None
2013-11-18 Injury None None
2013-11-13 Injury None None
2013-11-09 Injury None Insufficient Information
2013-11-06 Injury None None
2013-11-01 Injury None None
2013-10-24 Injury None None
2013-10-16 Injury None Insufficient Information
2013-10-14 Malfunction None None
2013-10-03 Injury None None
2013-09-27 Injury None Insufficient Information
2013-09-27 Injury None Insufficient Information
2013-09-27 Injury None None
2013-09-27 Injury None None
2013-09-26 Injury None None
2013-09-25 Injury None Insufficient Information
2013-09-23 Injury None None
2013-09-19 Injury None None
2013-09-09 Malfunction None None
2013-09-05 Injury None None
2013-09-03 Injury None Extrusion
2013-09-03 Injury None Extrusion
2013-08-28 Injury None None
2013-08-28 Malfunction None None
2013-08-23 Injury None None
2013-08-22 Injury None Migration or Expulsion of Device
2013-08-20 Injury None None
2013-08-16 Injury None None
2013-08-15 Injury None None
2013-08-12 Injury None None
2013-08-05 Injury None None
2013-08-02 Injury None None
2013-08-01 Injury None None
2013-08-01 Injury None None
2013-08-01 Injury None None
2013-07-26 Injury None None
2013-07-25 Malfunction None No Device Output
2013-07-23 Injury None None
2013-07-22 Injury None None
2013-07-22 Injury None None
2013-07-17 Injury None None
2013-07-16 Injury None None
2013-07-11 Injury None None
2013-07-10 Injury None None
2013-07-06 Injury None None
2013-07-05 Injury None None
2013-07-01 Injury None Insufficient Information
2013-06-27 Injury None None
2013-06-27 Malfunction None None
2013-06-24 Injury None None
2013-06-18 Injury None None
2013-06-14 Injury None None
2013-06-14 Injury None None
2013-06-14 Injury None None
2013-06-05 Injury None None
2013-05-30 Injury None None
2013-05-30 Injury None None
2013-05-28 Injury None None
2013-05-23 Injury None None
2013-05-22 Injury None None
2013-05-19 Injury None None
2013-05-10 Unknown None None
2013-05-09 Injury None None
2013-05-06 Injury None None
2013-04-30 Injury None None
2013-04-29 Injury None None
2013-04-29 Injury None None
2013-04-29 Injury None None
2013-04-19 Injury None None
2013-04-19 Injury None None
2013-04-15 Injury None None
2013-04-09 Injury None None
2013-04-08 Injury None None
2013-04-01 Injury None Device Operates Differently Than Expected
2013-03-25 Injury None None
2013-03-19 Injury None None
2013-03-13 Injury None None
2013-03-12 Injury None None
2013-03-12 Injury None None
2013-03-12 Injury None None
2013-03-04 Injury None None
2013-02-14 Injury None None
2013-02-07 Injury None None
2013-02-01 Injury None None
2013-01-28 Injury None None
2013-01-14 Injury None None
2013-01-04 Injury None None
2012-12-20 Injury None None
2012-12-18 Injury None None
2012-12-11 Injury None None
2012-12-04 Injury None None
2012-11-02 Injury None None
2012-10-24 Injury None None
2012-10-21 Injury None None
2012-10-21 Injury None None
2012-10-18 Injury None None
2012-10-17 Injury None None
2012-10-12 Injury None None
2012-10-05 Injury None None
2012-09-30 Injury None None
2012-09-27 Injury None None