CONFIRM

IMPLANTABLE CARDIAC MONITOR

This device is manufactured by ST JUDE MEDICAL, ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION.

The following problems were reported about this device:

Date Event Type Patient Problem Device Problem
2022-04-27 Malfunction Failure of Implant Product Quality Problem
2021-05-10 Malfunction Insufficient Information Insufficient Information
2020-06-22 Malfunction None Data Problem
2019-09-10 Death None Under-Sensing
2019-08-16 Injury None Failure to Interrogate
2019-05-30 Injury None Adverse Event Without Identified Device or Use Problem
2019-05-02 Malfunction None Data Problem
2019-04-18 Malfunction None Data Problem
2019-04-10 Injury None Inappropriate or Unexpected Reset
2019-04-01 Injury None Adverse Event Without Identified Device or Use Problem
2019-03-23 Malfunction None Under-Sensing
2019-03-19 Malfunction None Under-Sensing
2019-03-08 Injury None Adverse Event Without Identified Device or Use Problem
2019-03-06 Malfunction None Sensing Intermittently
2019-03-05 Malfunction None Under-Sensing
2019-02-19 Injury None Under-Sensing
2019-02-18 Injury None Battery Problem
2019-02-17 Malfunction None Under-Sensing
2019-02-17 Malfunction None Under-Sensing
2019-02-14 Malfunction None Failure to Interrogate
2019-02-11 Malfunction None Under-Sensing
2019-02-08 Malfunction None Inappropriate or Unexpected Reset
2019-02-07 Malfunction None Adverse Event Without Identified Device or Use Problem
2019-02-05 Malfunction None Adverse Event Without Identified Device or Use Problem
2019-02-04 Malfunction None Under-Sensing
2019-01-30 Injury None Under-Sensing
2019-01-30 Malfunction None Difficult to Interrogate
2019-01-30 Malfunction None Under-Sensing
2019-01-29 Malfunction None Under-Sensing
2019-01-27 Malfunction None Improper or Incorrect Procedure or Method, Patient-Device Incompatibility
2019-01-26 Malfunction None Under-Sensing
2019-01-25 Malfunction None Over-Sensing, Device Sensing Problem
2019-01-25 Malfunction None Under-Sensing
2019-01-24 Malfunction None Under-Sensing
2019-01-24 Injury None Under-Sensing
2019-01-24 Malfunction None Under-Sensing
2019-01-24 Malfunction None Under-Sensing
2019-01-22 Malfunction None Under-Sensing
2019-01-22 Malfunction None Under-Sensing
2019-01-22 Malfunction None Under-Sensing
2019-01-22 Malfunction None Under-Sensing
2019-01-22 Malfunction None Under-Sensing
2019-01-22 Malfunction None Under-Sensing
2019-01-22 Malfunction None Under-Sensing
2019-01-22 Malfunction None Under-Sensing
2019-01-22 Malfunction None Under-Sensing
2019-01-22 Malfunction None Under-Sensing
2019-01-22 Malfunction None Under-Sensing
2019-01-22 Malfunction None Under-Sensing
2019-01-21 Malfunction None Under-Sensing
2019-01-17 Malfunction None Under-Sensing
2019-01-16 Malfunction None Under-Sensing
2019-01-16 Malfunction None Under-Sensing
2019-01-16 Malfunction None Under-Sensing
2019-01-16 Malfunction None Under-Sensing
2019-01-16 Malfunction None Under-Sensing
2019-01-15 Injury None Under-Sensing
2019-01-14 Malfunction None Under-Sensing
2019-01-10 Malfunction None Under-Sensing
2019-01-08 Malfunction None Under-Sensing
2019-01-08 Malfunction None Under-Sensing
2019-01-07 Malfunction None Under-Sensing
2019-01-07 Malfunction None Failure to Interrogate
2019-01-07 Malfunction None Under-Sensing, Low Sensing Threshold
2019-01-05 Injury None Inappropriate or Unexpected Reset
2019-01-03 Malfunction None Difficult to Interrogate
2019-01-03 Malfunction None Difficult to Interrogate
2019-01-02 Malfunction None Sensing Intermittently
2018-12-28 Malfunction None Under-Sensing
2018-12-24 Malfunction None Under-Sensing
2018-12-21 Malfunction None Under-Sensing
2018-12-20 Malfunction None Under-Sensing
2018-12-20 Malfunction None Data Problem
2018-12-20 Malfunction None Under-Sensing
2018-12-19 Malfunction None Failure to Interrogate
2018-12-19 Malfunction None Failure to Interrogate, Under-Sensing
2018-12-18 Malfunction None Difficult to Interrogate
2018-12-18 Malfunction None Difficult to Interrogate
2018-12-18 Malfunction None Under-Sensing
2018-12-17 Malfunction None Under-Sensing, Data Problem
2018-12-17 Injury None Adverse Event Without Identified Device or Use Problem
2018-12-17 Malfunction None Under-Sensing
2018-12-14 Malfunction None Signal Artifact/Noise, Under-Sensing
2018-12-13 Malfunction None Under-Sensing
2018-12-13 Malfunction None Difficult to Interrogate, Device Displays Incorrect Message
2018-12-12 Injury None Adverse Event Without Identified Device or Use Problem
2018-12-12 Malfunction None Under-Sensing
2018-12-11 Malfunction None Under-Sensing
2018-12-11 Injury None Failure to Interrogate
2018-12-11 Malfunction None Under-Sensing
2018-12-11 Malfunction None Under-Sensing
2018-12-10 Malfunction None Difficult to Interrogate
2018-12-09 Malfunction None Failure to Sense, Under-Sensing
2018-12-05 Malfunction None Under-Sensing
2018-12-02 Malfunction None Under-Sensing
2018-12-01 Malfunction None Under-Sensing
2018-11-30 Malfunction None Communication or Transmission Problem
2018-11-30 Malfunction None Failure to Interrogate
2018-11-29 Injury None Wireless Communication Problem
2018-11-29 Injury None Premature Discharge of Battery, Failure to Interrogate
2018-11-28 Malfunction None Communication or Transmission Problem
2018-11-28 Malfunction None Under-Sensing
2018-11-27 Malfunction None Failure to Interrogate
2018-11-27 Malfunction None Under-Sensing
2018-11-27 Malfunction None Premature Discharge of Battery, Failure to Interrogate
2018-11-23 Malfunction None Under-Sensing
2018-11-23 Malfunction None Under-Sensing
2018-11-23 Malfunction None Under-Sensing
2018-11-23 Malfunction None Over-Sensing
2018-11-22 Malfunction None Under-Sensing
2018-11-22 Malfunction None Inappropriate or Unexpected Reset
2018-11-22 Malfunction None Under-Sensing
2018-11-22 Malfunction None Failure to Interrogate
2018-11-21 Malfunction None Under-Sensing
2018-11-21 Malfunction None Under-Sensing
2018-11-21 Malfunction None Under-Sensing
2018-11-21 Malfunction None Under-Sensing
2018-11-21 Malfunction None Under-Sensing
2018-11-19 Malfunction None Under-Sensing
2018-11-19 Malfunction None Failure to Interrogate
2018-11-19 Malfunction None Under-Sensing
2018-11-17 Malfunction None Under-Sensing
2018-11-16 Malfunction None Signal Artifact/Noise
2018-11-15 Malfunction None Premature Discharge of Battery, Failure to Interrogate
2018-11-15 Malfunction None Data Problem
2018-11-15 Malfunction None Under-Sensing
2018-11-14 Malfunction None Failure to Interrogate
2018-11-14 Malfunction None Under-Sensing
2018-11-14 Malfunction None Data Problem
2018-11-14 Malfunction None Under-Sensing
2018-11-13 Injury None Failure to Interrogate
2018-11-13 Injury None Adverse Event Without Identified Device or Use Problem
2018-11-12 Malfunction None Under-Sensing
2018-11-09 Malfunction None Failure to Interrogate
2018-11-08 Malfunction None Under-Sensing
2018-11-07 Malfunction None Premature Discharge of Battery
2018-11-07 Malfunction None Under-Sensing
2018-11-05 Malfunction None Under-Sensing
2018-11-05 Malfunction None Failure to Interrogate, Inappropriate or Unexpected Reset
2018-11-03 Malfunction None Under-Sensing
2018-11-03 Malfunction None Under-Sensing
2018-11-03 Malfunction None Under-Sensing
2018-11-02 Injury None Premature Discharge of Battery
2018-11-01 Malfunction None Under-Sensing
2018-10-31 Malfunction None Under-Sensing
2018-10-31 Malfunction None Under-Sensing
2018-10-31 Injury None Difficult to Interrogate, Inappropriate or Unexpected Reset
2018-10-29 Injury None Failure to Interrogate
2018-10-29 Malfunction None Over-Sensing, Under-Sensing
2018-10-29 Malfunction None Communication or Transmission Problem
2018-10-28 Malfunction None Under-Sensing
2018-10-26 Injury None Adverse Event Without Identified Device or Use Problem
2018-10-26 Malfunction None Under-Sensing
2018-10-26 Injury None Under-Sensing
2018-10-25 Malfunction None Under-Sensing
2018-10-25 Malfunction None Sensing Intermittently
2018-10-24 Malfunction None Data Problem
2018-10-24 Malfunction None Data Problem
2018-10-23 Malfunction None Signal Artifact/Noise, Difficult to Interrogate
2018-10-22 Malfunction None Failure to Interrogate, Failure to Sense
2018-10-22 Malfunction None Under-Sensing
2018-10-20 Malfunction None Over-Sensing
2018-10-19 Malfunction None Premature Discharge of Battery
2018-10-19 Malfunction None Failure to Interrogate
2018-10-18 Malfunction None Under-Sensing
2018-10-18 Malfunction None Under-Sensing
2018-10-18 Malfunction None Under-Sensing
2018-10-17 Malfunction None Sensing Intermittently
2018-10-17 Malfunction None Under-Sensing
2018-10-16 Malfunction None Failure to Sense
2018-10-16 Injury None Failure to Interrogate, Inappropriate or Unexpected Reset
2018-10-15 Malfunction None Under-Sensing
2018-10-07 Malfunction None Over-Sensing, Sensing Intermittently
2018-10-03 Malfunction None Over-Sensing, Under-Sensing
2018-10-03 Malfunction None Incorrect Measurement
2018-10-02 Malfunction None Failure to Interrogate
2018-10-01 Malfunction None Under-Sensing
2018-10-01 Malfunction None Data Problem
2018-09-28 Injury None Failure to Interrogate
2018-09-28 Malfunction None Data Problem
2018-09-28 Injury None Failure to Interrogate
2018-09-28 Malfunction None Under-Sensing
2018-09-25 Malfunction None Failure to Interrogate
2018-09-19 Injury None Failure to Interrogate
2018-09-19 Injury None Failure to Interrogate
2018-09-19 Malfunction None Under-Sensing
2018-09-19 Malfunction None Failure to Interrogate
2018-09-19 Malfunction None Inappropriate or Unexpected Reset
2018-09-18 Malfunction None Under-Sensing
2018-09-17 Malfunction None Failure to Sense
2018-09-17 Malfunction None Over-Sensing
2018-09-17 Injury None Adverse Event Without Identified Device or Use Problem
2018-09-17 Malfunction None Migration or Expulsion of Device
2018-09-17 Malfunction None Under-Sensing
2018-09-13 Malfunction None Over-Sensing
2018-09-12 Malfunction None Image Display Error/Artifact
2018-09-12 Malfunction None Under-Sensing, Device Sensing Problem
2018-09-12 Malfunction None Failure to Interrogate
2018-09-12 Injury None Failure to Interrogate
2018-09-12 Malfunction None Signal Artifact/Noise, Under-Sensing
2018-09-12 Malfunction None Over-Sensing
2018-09-12 Malfunction None Under-Sensing
2018-09-12 Injury None Data Problem
2018-09-10 Malfunction None Under-Sensing
2018-09-10 Malfunction None Under-Sensing
2018-09-06 Malfunction None Failure to Interrogate
2018-09-01 Malfunction None Data Problem
2018-08-30 Malfunction None Pacemaker Found in Back-Up Mode
2018-08-30 Malfunction None Data Problem
2018-08-29 Malfunction None Under-Sensing
2018-08-28 Injury None Adverse Event Without Identified Device or Use Problem
2018-08-27 Malfunction None Data Problem
2018-08-24 Malfunction None Data Problem
2018-08-20 Malfunction None Premature Discharge of Battery
2018-08-17 Injury None Wireless Communication Problem
2018-08-17 Malfunction None Under-Sensing
2018-08-16 Malfunction None Under-Sensing
2018-08-16 Malfunction None Under-Sensing
2018-08-16 Malfunction None Under-Sensing
2018-08-13 Malfunction None Under-Sensing
2018-08-13 Malfunction None Under-Sensing
2018-08-13 Malfunction None Under-Sensing
2018-08-10 Malfunction None Under-Sensing
2018-08-10 Malfunction None Under-Sensing
2018-08-07 Malfunction None Under-Sensing
2018-08-06 Malfunction None Under-Sensing
2018-08-04 Malfunction None Failure to Sense
2018-08-03 Malfunction None Failure to Interrogate
2018-08-03 Malfunction None Under-Sensing
2018-08-02 Injury None Failure to Interrogate
2018-08-02 Malfunction None Under-Sensing
2018-08-02 Malfunction None Communication or Transmission Problem
2018-08-02 Malfunction None Over-Sensing
2018-07-31 Malfunction None Under-Sensing
2018-07-27 Malfunction None Under-Sensing
2018-07-26 Malfunction None Under-Sensing
2018-07-26 Malfunction None Data Problem
2018-07-26 Malfunction None Over-Sensing
2018-07-26 Malfunction None Over-Sensing
2018-07-25 Injury None Under-Sensing
2018-07-25 Malfunction None Failure to Interrogate
2018-07-24 Injury None Migration or Expulsion of Device
2018-07-23 Malfunction None Failure to Interrogate
2018-07-20 Malfunction None Under-Sensing
2018-07-20 Malfunction None Under-Sensing
2018-07-18 Malfunction None Device Damaged Prior to Use
2018-07-17 Injury None Failure to Interrogate
2018-07-16 Malfunction None Data Problem
2018-07-16 Malfunction None Failure to Sense, Under-Sensing
2018-07-15 Injury None Over-Sensing
2018-07-13 Malfunction None Under-Sensing
2018-07-13 Malfunction None Failure to Sense
2018-07-13 Malfunction None Under-Sensing
2018-07-11 Malfunction None Failure to Interrogate
2018-07-09 Malfunction None Under-Sensing
2018-07-09 Malfunction None Under-Sensing
2018-07-08 Malfunction None Sensing Intermittently, Under-Sensing
2018-07-06 Malfunction None Wireless Communication Problem
2018-07-05 Malfunction None Under-Sensing
2018-07-03 Malfunction None Under-Sensing
2018-07-03 Malfunction None Under-Sensing
2018-07-02 Malfunction None Signal Artifact/Noise, Over-Sensing, Under-Sensing
2018-06-28 Malfunction None Over-Sensing
2018-06-28 Malfunction None Over-Sensing, Under-Sensing
2018-06-26 Malfunction None Failure to Interrogate
2018-06-25 Malfunction None Under-Sensing
2018-06-25 Malfunction None Failure to Interrogate
2018-06-24 Malfunction None Under-Sensing, Migration
2018-06-21 Injury None Failure to Interrogate
2018-06-20 Malfunction None Data Problem
2018-06-19 Malfunction None Over-Sensing
2018-06-18 Malfunction None Under-Sensing
2018-06-18 Malfunction None Under-Sensing
2018-06-15 Malfunction None Under-Sensing
2018-06-14 Injury None Under-Sensing
2018-06-13 Injury None Failure to Interrogate
2018-06-12 Injury None Failure to Interrogate
2018-06-12 Malfunction None Failure to Interrogate
2018-06-12 Malfunction None Over-Sensing, Incorrect Interpretation of Signal
2018-06-10 Malfunction None Under-Sensing
2018-06-10 Malfunction None Under-Sensing
2018-06-08 Malfunction None Device Displays Incorrect Message
2018-06-08 Malfunction None Communication or Transmission Problem
2018-06-08 Malfunction None Under-Sensing
2018-06-06 Malfunction None Failure to Interrogate
2018-06-06 Malfunction None Under-Sensing
2018-06-03 Injury None Adverse Event Without Identified Device or Use Problem
2018-06-03 Malfunction None Under-Sensing
2018-05-31 Malfunction None Under-Sensing
2018-05-31 Malfunction None Sensing Intermittently
2018-05-30 Malfunction None Signal Artifact/Noise, Under-Sensing
2018-05-30 Malfunction None Data Problem
2018-05-30 Malfunction None Data Problem
2018-05-30 Malfunction None Under-Sensing
2018-05-28 Malfunction None Under-Sensing
2018-05-28 Malfunction None Data Problem
2018-05-28 Malfunction None Under-Sensing
2018-05-26 Malfunction None Failure to Sense
2018-05-25 Injury None Under-Sensing
2018-05-24 Malfunction None Under-Sensing
2018-05-24 Malfunction None Data Problem
2018-05-23 Malfunction None Under-Sensing
2018-05-22 Malfunction None Failure to Sense
2018-05-17 Injury None Failure to Interrogate
2018-05-15 Injury None Premature Discharge of Battery, Failure to Interrogate
2018-05-14 Malfunction None No Display/Image
2018-05-11 Malfunction None Under-Sensing
2018-05-09 Malfunction None Under-Sensing
2018-05-06 Malfunction None Under-Sensing
2018-05-06 Malfunction None Sensing Intermittently
2018-05-04 Malfunction None Under-Sensing
2018-05-04 Malfunction None Data Problem
2018-04-30 Malfunction None Difficult to Interrogate
2018-04-27 Injury None Failure to Sense
2018-04-26 Malfunction None Under-Sensing
2018-04-24 Injury None Failure to Interrogate
2018-04-24 Malfunction None Image Display Error/Artifact
2018-04-20 Malfunction None Difficult to Interrogate, Inappropriate or Unexpected Reset
2018-04-20 Injury None Under-Sensing, Low Sensing Threshold
2018-04-20 Malfunction None Difficult to Interrogate, Under-Sensing
2018-04-20 Malfunction None Under-Sensing, Wireless Communication Problem
2018-04-19 Malfunction None Wireless Communication Problem
2018-04-19 Malfunction None Under-Sensing
2018-04-18 Malfunction None Under-Sensing
2018-04-18 Malfunction None Inappropriate or Unexpected Reset
2018-04-17 Malfunction None Under-Sensing
2018-04-16 Malfunction None Under-Sensing
2018-04-16 Malfunction None Difficult to Interrogate, Under-Sensing
2018-04-14 Malfunction None Under-Sensing
2018-04-12 Malfunction None Device Displays Incorrect Message, Data Problem
2018-04-09 Malfunction None Under-Sensing
2018-04-07 Injury None Migration or Expulsion of Device
2018-04-04 Injury None Failure to Interrogate
2018-04-03 Malfunction None Under-Sensing
2018-04-03 Malfunction None Signal Artifact/Noise, Under-Sensing
2018-04-02 Injury None Signal Artifact/Noise
2018-03-30 Injury None Failure to Interrogate
2018-03-30 Injury None Failure to Interrogate, Wireless Communication Problem
2018-03-29 Malfunction None Under-Sensing
2018-03-27 Malfunction None Migration or Expulsion of Device, Under-Sensing
2018-03-27 Malfunction None Over-Sensing
2018-03-27 Malfunction None Under-Sensing
2018-03-26 Malfunction None Difficult to Interrogate, Under-Sensing
2018-03-26 Malfunction None Over-Sensing
2018-03-26 Malfunction None Under-Sensing
2018-03-22 Malfunction None Under-Sensing
2018-03-22 Malfunction None Under-Sensing
2018-03-21 Malfunction None Under-Sensing
2018-03-21 Malfunction None Under-Sensing
2018-03-20 Injury None Detachment Of Device Component
2018-03-20 Malfunction None Under-Sensing
2018-03-19 Malfunction None Under-Sensing
2018-03-19 Malfunction None Under-Sensing
2018-03-17 Malfunction None Under-Sensing
2018-03-16 Malfunction None Under-Sensing
2018-03-16 Malfunction None Inappropriate or Unexpected Reset
2018-03-16 Malfunction None Under-Sensing, Device Sensing Problem
2018-03-15 Malfunction None Under-Sensing
2018-03-14 Malfunction None Under-Sensing
2018-03-14 Malfunction None Under-Sensing
2018-03-14 Malfunction None Under-Sensing
2018-03-14 Malfunction None Under-Sensing
2018-03-14 Malfunction None Under-Sensing
2018-03-14 Malfunction None Failure to Interrogate, Device Displays Incorrect Message
2018-03-13 Malfunction None Under-Sensing
2018-03-13 Malfunction None Under-Sensing
2018-03-13 Malfunction None Under-Sensing
2018-03-12 Injury None Failure to Interrogate, Inappropriate or Unexpected Reset
2018-03-12 Malfunction None Under-Sensing
2018-03-08 Malfunction None Under-Sensing
2018-03-08 Malfunction None Inappropriate or Unexpected Reset
2018-03-08 Malfunction None Difficult to Interrogate, Under-Sensing
2018-03-07 Malfunction None Inappropriate or Unexpected Reset
2018-03-07 Malfunction None Under-Sensing
2018-03-06 Malfunction None Over-Sensing
2018-03-05 Malfunction None Under-Sensing
2018-03-02 Injury None Communication or Transmission Problem
2018-03-01 Malfunction None Under-Sensing
2018-02-28 Malfunction None Failure to Interrogate
2018-02-27 Malfunction None Electromagnetic Interference
2018-02-26 Malfunction None Under-Sensing
2018-02-23 Malfunction None Under-Sensing
2018-02-22 Malfunction None Under-Sensing
2018-02-22 Malfunction None Under-Sensing
2018-02-22 Malfunction None Under-Sensing
2018-02-21 Malfunction None Under-Sensing
2018-02-21 Malfunction None Under-Sensing
2018-02-21 Malfunction None Under-Sensing
2018-02-21 Malfunction None Under-Sensing
2018-02-21 Malfunction None Under-Sensing
2018-02-21 Malfunction None Under-Sensing
2018-02-21 Malfunction None Under-Sensing
2018-02-20 Malfunction None Data Problem
2018-02-20 Injury None Migration or Expulsion of Device
2018-02-20 Malfunction None Under-Sensing
2018-02-20 Injury None Migration or Expulsion of Device
2018-02-18 Malfunction None Under-Sensing
2018-02-16 Malfunction None Difficult to Interrogate
2018-02-15 Injury None Premature Discharge of Battery, Failure to Interrogate
2018-02-15 Malfunction None Under-Sensing
2018-02-14 Malfunction None Under-Sensing
2018-02-14 Malfunction None Under-Sensing
2018-02-14 Malfunction None Under-Sensing
2018-02-12 Injury None Adverse Event Without Identified Device or Use Problem
2018-02-12 Malfunction None Failure to Interrogate
2018-02-08 Malfunction None Under-Sensing
2018-02-08 Malfunction None Under-Sensing
2018-02-07 Malfunction None Under-Sensing
2018-02-07 Malfunction None Under-Sensing
2018-02-07 Malfunction None Data Problem
2018-02-06 Malfunction None Data Problem
2018-02-06 Malfunction None Under-Sensing
2018-02-02 Malfunction None Under-Sensing
2018-01-31 Injury None Failure to Interrogate
2018-01-29 Malfunction None Device Displays Incorrect Message
2018-01-29 Malfunction None Failure to Interrogate
2018-01-29 Malfunction None Under-Sensing
2018-01-26 Malfunction None Under-Sensing
2018-01-26 Malfunction None Under-Sensing
2018-01-26 Malfunction None Data Problem
2018-01-24 Malfunction None Failure to Interrogate
2018-01-24 Malfunction None Incorrect Measurement
2018-01-22 Injury None Failure to Capture, Inappropriate or Unexpected Reset
2018-01-22 Malfunction None Under-Sensing
2018-01-19 Malfunction None Device Sensing Problem
2018-01-19 Injury None Device Sensing Problem
2018-01-18 Injury None Under-Sensing
2018-01-18 Malfunction None Failure to Interrogate
2018-01-17 Malfunction None Failure to Interrogate
2018-01-17 Malfunction None Defective Device, Communication or Transmission Problem
2018-01-16 Malfunction None Difficult to Interrogate
2018-01-16 Malfunction None Under-Sensing
2018-01-16 Malfunction None Inappropriate or Unexpected Reset
2018-01-16 Malfunction None Under-Sensing
2018-01-13 Malfunction None Under-Sensing
2018-01-12 Malfunction None Under-Sensing, Device Sensing Problem
2018-01-12 Malfunction None Over-Sensing
2018-01-11 Malfunction None Under-Sensing
2018-01-11 Malfunction None Under-Sensing
2018-01-11 Injury None Failure to Interrogate
2018-01-10 Malfunction None Under-Sensing
2018-01-09 Malfunction None Failure to Sense
2018-01-09 Malfunction None Under-Sensing
2018-01-08 Malfunction None Under-Sensing
2018-01-08 Malfunction None Device Sensing Problem
2018-01-08 Malfunction None Failure to Sense, Under-Sensing
2018-01-03 Malfunction None Under-Sensing
2017-12-29 Malfunction None Under-Sensing
2017-12-22 Malfunction None Under-Sensing
2017-12-21 Malfunction None Under-Sensing
2017-12-21 Malfunction None Under-Sensing
2017-12-20 Malfunction None Under-Sensing
2017-12-20 Malfunction None Signal Artifact/Noise, Under-Sensing, Communication or Transmission Problem
2017-12-20 Malfunction None Failure to Interrogate, Data Problem
2017-12-19 Malfunction None Under-Sensing
2017-12-18 Malfunction None Data Problem
2017-12-18 Injury None Failure to Interrogate
2017-12-18 Injury None Failure to Interrogate, Inappropriate or Unexpected Reset
2017-12-15 Malfunction None Under-Sensing
2017-12-15 Malfunction None Signal Artifact/Noise
2017-12-15 Malfunction None Under-Sensing
2017-12-15 Malfunction None Under-Sensing
2017-12-13 Malfunction None Under-Sensing
2017-12-13 Malfunction None Incorrect Interpretation of Signal
2017-12-13 Malfunction None Wireless Communication Problem
2017-12-12 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-12 Malfunction None Difficult to Interrogate
2017-12-11 Malfunction None Under-Sensing
2017-12-11 Malfunction None Signal Artifact/Noise
2017-12-11 Malfunction None Under-Sensing
2017-12-08 Malfunction None Failure to Interrogate
2017-12-08 Malfunction None Under-Sensing
2017-12-08 Malfunction None Under-Sensing
2017-12-07 Malfunction None Under-Sensing
2017-12-07 Malfunction None Under-Sensing
2017-12-06 Malfunction None Under-Sensing
2017-12-05 Malfunction None Sensing Intermittently
2017-12-05 Malfunction None Sensing Intermittently
2017-12-05 Injury None Failure to Interrogate
2017-12-04 Malfunction None Under-Sensing
2017-12-02 Malfunction None Failure to Sense
2017-12-01 Malfunction None Incorrect Interpretation of Signal, Under-Sensing
2017-11-30 Malfunction None Break
2017-11-30 Injury None Inappropriate or Unexpected Reset
2017-11-28 Malfunction None Under-Sensing, Data Problem
2017-11-28 Malfunction None Failure to Interrogate
2017-11-27 Malfunction None Under-Sensing
2017-11-24 Malfunction None Under-Sensing
2017-11-22 Malfunction None Under-Sensing
2017-11-21 Malfunction None Under-Sensing
2017-11-21 Malfunction None Data Problem
2017-11-20 Malfunction None Under-Sensing
2017-11-19 Malfunction None Under-Sensing
2017-11-18 Malfunction None Under-Sensing
2017-11-15 Malfunction None Under-Sensing
2017-11-15 Malfunction None Signal Artifact/Noise, Under-Sensing
2017-11-15 Injury None Adverse Event Without Identified Device or Use Problem
2017-11-15 Malfunction None Communication or Transmission Problem
2017-11-14 Malfunction None Signal Artifact/Noise, Under-Sensing
2017-11-13 Malfunction None Battery Problem
2017-11-13 Malfunction None Under-Sensing
2017-11-13 Malfunction None Under-Sensing
2017-11-13 Malfunction None Under-Sensing
2017-11-13 Malfunction None Data Problem
2017-11-12 Malfunction None Under-Sensing
2017-11-10 Malfunction None Data Problem
2017-11-10 Malfunction None Under-Sensing
2017-11-08 Malfunction None Under-Sensing
2017-11-08 Injury None Data Problem
2017-11-08 Malfunction None Signal Artifact/Noise, Under-Sensing
2017-11-07 Malfunction None Under-Sensing
2017-11-02 Malfunction None Under-Sensing
2017-11-02 Malfunction None Under-Sensing
2017-11-02 Injury None Signal Artifact/Noise, Over-Sensing
2017-11-01 Malfunction None Difficult to Interrogate, Data Problem
2017-11-01 Malfunction None Failure to Interrogate
2017-11-01 Malfunction None Under-Sensing
2017-11-01 Malfunction None Failure to Interrogate
2017-10-31 Malfunction None Under-Sensing
2017-10-30 Malfunction None Signal Artifact/Noise, Under-Sensing
2017-10-30 Malfunction None Under-Sensing
2017-10-29 Malfunction None Under-Sensing, Device Sensing Problem
2017-10-28 Malfunction None Communication or Transmission Problem
2017-10-27 Malfunction None Failure to Interrogate
2017-10-27 Malfunction None Under-Sensing
2017-10-26 Malfunction None Inappropriate or Unexpected Reset
2017-10-26 Malfunction None Inappropriate or Unexpected Reset
2017-10-25 Malfunction None Failure to Interrogate
2017-10-25 Malfunction None Wireless Communication Problem
2017-10-25 Malfunction None Communication or Transmission Problem
2017-10-24 Injury None Communication or Transmission Problem
2017-10-24 Malfunction None Failure to Interrogate, Device Displays Incorrect Message
2017-10-23 Malfunction None Data Problem
2017-10-21 Malfunction None Under-Sensing
2017-10-19 Malfunction None Wireless Communication Problem
2017-10-19 Malfunction None Incorrect Interpretation of Signal, Under-Sensing, Wireless Communication Problem
2017-10-19 Malfunction None Under-Sensing
2017-10-19 Malfunction None Failure to Sense
2017-10-17 Malfunction None Under-Sensing
2017-10-17 Malfunction None Failure to Interrogate
2017-10-17 Malfunction None Over-Sensing, Incorrect Interpretation of Signal, Under-Sensing
2017-10-16 Malfunction None Inappropriate or Unexpected Reset
2017-10-13 Malfunction None Wireless Communication Problem
2017-10-13 Malfunction None Under-Sensing, Communication or Transmission Problem
2017-10-13 Injury None Signal Artifact/Noise
2017-10-11 Malfunction None Communication or Transmission Problem, Data Problem
2017-10-11 Malfunction None Under-Sensing
2017-10-08 Malfunction None Under-Sensing, Device Sensing Problem
2017-10-07 Malfunction None Under-Sensing
2017-10-05 Injury None Inappropriate or Unexpected Reset
2017-10-04 Malfunction None Communication or Transmission Problem, Positioning Problem
2017-10-03 Malfunction None Signal Artifact/Noise, Data Problem
2017-10-02 Malfunction None Under-Sensing
2017-10-02 Injury None Failure to Interrogate, Data Problem
2017-10-01 Malfunction None Under-Sensing
2017-09-28 Malfunction None Under-Sensing
2017-09-26 Malfunction None Communication or Transmission Problem
2017-09-26 Injury None Adverse Event Without Identified Device or Use Problem
2017-09-26 Injury None Failure to Interrogate
2017-09-17 Malfunction None Under-Sensing
2017-09-15 Malfunction None Signal Artifact/Noise, Under-Sensing
2017-09-13 Injury None Premature Discharge of Battery
2017-09-13 Malfunction None Under-Sensing
2017-09-07 Malfunction None Premature Discharge of Battery, Inappropriate or Unexpected Reset
2017-09-02 Malfunction None Under-Sensing
2017-09-02 Malfunction None Under-Sensing
2017-08-31 Malfunction None Premature Discharge of Battery
2017-08-29 Malfunction None Inappropriate or Unexpected Reset
2017-08-28 Malfunction None Under-Sensing
2017-08-01 Malfunction None Failure to Interrogate, Data Problem
2017-07-31 Malfunction None Data Problem
2017-07-24 Malfunction None Inappropriate or Unexpected Reset
2017-07-18 Malfunction None Device Difficult to Program or Calibrate
2017-07-18 Malfunction None Device Difficult to Program or Calibrate
2017-07-16 Malfunction None Under-Sensing
2017-07-13 Malfunction None Inappropriate or Unexpected Reset
2017-07-07 Malfunction None Data Problem
2017-07-06 Malfunction None Inappropriate or Unexpected Reset
2017-07-05 Malfunction None Under-Sensing
2017-07-03 Malfunction None Under-Sensing
2017-06-18 Malfunction None Incorrect Interpretation of Signal, Under-Sensing
2017-06-12 Malfunction None Data Problem
2017-06-05 Malfunction None Incorrect Measurement
2017-05-27 Malfunction None Under-Sensing
2017-05-25 Malfunction None Data Problem
2017-05-25 Malfunction None Inappropriate or Unexpected Reset
2017-05-24 Malfunction None Data Problem
2017-05-17 Malfunction None Pacemaker Found in Back-Up Mode
2017-05-15 Malfunction None Data Problem
2017-05-15 Malfunction None Data Problem
2017-05-10 Malfunction None Pacemaker Found in Back-Up Mode
2017-05-08 Malfunction None Communication or Transmission Problem
2017-05-04 Malfunction None Inappropriate or Unexpected Reset
2017-04-26 Injury None Failure to Interrogate
2017-04-14 Malfunction None Under-Sensing
2017-03-30 Malfunction None Inappropriate or Unexpected Reset
2017-03-23 Malfunction None Under-Sensing, Device Operates Differently Than Expected
2017-03-22 Malfunction None Wireless Communication Problem
2017-03-22 Malfunction None Connection Problem
2017-03-20 Malfunction None Inappropriate or Unexpected Reset
2017-03-09 Malfunction None Device Displays Incorrect Message
2017-03-07 Malfunction None Inappropriate or Unexpected Reset
2017-03-01 Malfunction None Inappropriate or Unexpected Reset
2017-03-01 Malfunction None Inappropriate or Unexpected Reset
2017-02-15 Malfunction None Inappropriate or Unexpected Reset
2017-02-14 Malfunction None Pacemaker Found in Back-Up Mode
2017-02-10 Malfunction None Failure to Interrogate, Inappropriate or Unexpected Reset
2017-02-08 Injury None Premature Discharge of Battery, Failure to Interrogate
2017-01-30 Malfunction None Under-Sensing
2017-01-27 Malfunction None Data Problem
2017-01-26 Malfunction None Inappropriate or Unexpected Reset
2017-01-19 Malfunction None Under-Sensing
2017-01-13 Malfunction None Programming Issue
2017-01-09 Malfunction None Inappropriate or Unexpected Reset
2017-01-04 Malfunction None Failure to Interrogate
2016-12-30 Injury None Inappropriate or Unexpected Reset
2016-12-29 Injury None Signal Artifact/Noise
2016-12-16 Malfunction None Premature Elective Replacement Indicator
2016-12-16 Injury None Telemetry Discrepancy
2016-12-14 Malfunction None Inappropriate or Unexpected Reset
2016-12-07 Malfunction None Under-Sensing
2016-12-07 Malfunction None Failure to Interrogate
2016-12-05 Malfunction None Issue With Displayed Error Message
2016-11-30 Malfunction None Failure to Interrogate
2016-11-29 Malfunction None Failure to Interrogate
2016-11-29 Malfunction None Difficult to Interrogate
2016-11-25 Malfunction None Data Problem
2016-11-25 Malfunction None Failure to Sense, Loss of Data
2016-11-25 Malfunction None Pacemaker Found in Back-Up Mode
2015-05-05 Malfunction None Sensing Intermittently
2015-05-05 Injury None Device Operates Differently Than Expected
2015-05-05 Injury None Failure to Interrogate
2015-04-23 Malfunction None Inappropriate or Unexpected Reset
2015-04-10 Malfunction None Difficult to Interrogate
2015-04-01 Malfunction None Failure to Interrogate
2015-03-27 Injury None Failure to Interrogate
2015-03-27 Malfunction None Under-Sensing
2015-03-25 Malfunction None Under-Sensing
2015-03-23 Injury None Failure to Interrogate, Battery Problem
2015-03-20 Malfunction None Out-Of-Box Failure, Problem with Software Installation
2015-03-20 Malfunction None Problem with Software Installation
2015-03-20 Injury None Failure to Interrogate
2015-03-19 Malfunction None Failure to Interrogate
2015-03-18 Malfunction None Device Operates Differently Than Expected
2015-03-16 Malfunction None Device Displays Incorrect Message
2015-03-16 Injury None Telemetry Discrepancy
2015-03-16 Malfunction None Programming Issue
2015-03-16 Malfunction None Under-Sensing
2015-03-11 Malfunction None Failure to Interrogate, Device Displays Incorrect Message
2015-03-10 Malfunction None Pacemaker Found in Back-Up Mode
2015-03-10 Injury None Adverse Event Without Identified Device or Use Problem
2015-03-04 Malfunction None Failure to Interrogate, Pacemaker Found in Back-Up Mode
2015-03-02 Malfunction None Out-Of-Box Failure, Problem with Software Installation
2015-02-28 Malfunction None Under-Sensing
2015-02-26 Injury None Failure to Interrogate
2015-02-26 Malfunction None Pacemaker Found in Back-Up Mode
2015-02-25 Malfunction None Failure to Interrogate
2015-02-24 Malfunction None Out-Of-Box Failure, Problem with Software Installation
2015-02-24 Injury None Failure to Interrogate
2015-02-24 Malfunction None Out-Of-Box Failure, Problem with Software Installation
2015-02-24 Malfunction None Pacemaker Found in Back-Up Mode
2015-02-24 Malfunction None Failure to Interrogate, Pacemaker Found in Back-Up Mode
2015-02-23 Malfunction None Under-Sensing
2015-02-18 Malfunction None Failure to Interrogate, Pacemaker Found in Back-Up Mode
2015-02-13 Malfunction None Sensing Intermittently
2015-02-12 Malfunction None Device Displays Incorrect Message
2015-02-12 Malfunction None Over-Sensing
2015-02-10 Injury None Failure to Interrogate
2015-02-07 Malfunction None Sensing Intermittently
2015-02-04 Injury None Pacemaker Found in Back-Up Mode
2015-02-03 Malfunction None Device Operates Differently Than Expected
2015-01-16 Malfunction None Computer Software Problem
2014-07-10 Injury None Adverse Event Without Identified Device or Use Problem
2014-07-08 Injury None Over-Sensing
2014-07-08 Injury None Failure to Interrogate
2014-05-29 Malfunction None Over-Sensing, Device Sensing Problem
2014-05-29 Injury None Failure to Interrogate
2014-05-28 Malfunction None Device Operates Differently Than Expected
2014-05-27 Malfunction None Failure to Interrogate
2014-05-27 Malfunction None Pacemaker Found in Back-Up Mode
2014-05-21 Malfunction None Device Operates Differently Than Expected
2014-05-16 Malfunction None Pacemaker Found in Back-Up Mode, Device Displays Incorrect Message
2014-05-15 Malfunction None Device Displays Incorrect Message
2014-05-12 Malfunction None Incorrect Measurement
2014-05-09 Malfunction None Pacemaker Found in Back-Up Mode
2014-05-06 Malfunction None Sensing Intermittently, Under-Sensing
2014-05-06 Malfunction None Under-Sensing
2014-05-01 Malfunction None Failure to Sense
2014-04-30 Injury None Premature Discharge of Battery, Failure to Interrogate
2014-04-28 Malfunction None Under-Sensing
2014-04-28 Malfunction None Over-Sensing
2014-04-26 Malfunction None Under-Sensing
2014-04-24 Malfunction None Device Displays Incorrect Message
2014-04-21 Malfunction None Sensing Intermittently
2014-04-21 Malfunction None Under-Sensing
2014-04-21 Injury None Failure to Interrogate
2014-04-17 Malfunction None Over-Sensing
2014-04-16 Malfunction None Sensing Intermittently, Under-Sensing
2014-04-16 Malfunction None Device Displays Incorrect Message
2014-04-15 Malfunction None Over-Sensing
2014-04-15 Malfunction None Sensing Intermittently, Under-Sensing
2014-04-15 Malfunction None Device Displays Incorrect Message
2014-04-09 Injury None Sensing Intermittently
2014-04-08 Malfunction None Under-Sensing
2014-04-03 Malfunction None Failure to Sense
2014-04-03 Malfunction None Sensing Intermittently, Under-Sensing
2014-04-03 Injury None Difficult to Interrogate, Device Displays Incorrect Message
2014-04-03 Malfunction None Failure to Interrogate, Device Displays Incorrect Message
2014-04-02 Malfunction None Sensing Intermittently, Under-Sensing
2014-04-01 Malfunction None Device Displays Incorrect Message
2014-03-20 Malfunction None Sensing Intermittently, Under-Sensing
2014-03-20 Malfunction None Pacemaker Found in Back-Up Mode
2014-03-19 Injury None Pacemaker Found in Back-Up Mode
2014-03-19 Malfunction None Failure to Interrogate, Pacemaker Found in Back-Up Mode, Device Displays Incorrect Message
2014-03-19 Malfunction None Under-Sensing
2014-03-19 Malfunction None Pacemaker Found in Back-Up Mode
2014-03-18 Malfunction None Device Displays Incorrect Message
2014-03-17 Malfunction None Over-Sensing
2014-03-17 Malfunction None Sensing Intermittently, Failure to Sense
2014-03-14 Injury None Invalid Sensing
2014-03-13 Malfunction None Over-Sensing
2014-03-12 Malfunction None Failure to Interrogate, Device Displays Incorrect Message
2014-03-12 Malfunction None Pacemaker Found in Back-Up Mode
2014-03-12 Malfunction None Adverse Event Without Identified Device or Use Problem
2014-03-05 Malfunction None Pacemaker Found in Back-Up Mode
2014-03-05 Malfunction None Sensing Intermittently
2014-02-26 Injury None Pacemaker Found in Back-Up Mode, Telemetry Discrepancy
2014-02-26 Malfunction None Device Displays Incorrect Message
2014-02-26 Malfunction None Sensing Intermittently, Under-Sensing
2014-02-26 Malfunction None Sensing Intermittently, Under-Sensing
2014-02-26 Malfunction None Under-Sensing
2014-02-25 Malfunction None Device Displays Incorrect Message
2014-02-21 Malfunction None Failure to Sense
2014-02-20 Malfunction None Pacemaker Found in Back-Up Mode
2014-02-20 Malfunction None Pacemaker Found in Back-Up Mode, Invalid Sensing
2014-02-19 Malfunction None Device Displays Incorrect Message
2014-02-19 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2014-02-19 Injury None Sensing Intermittently, Under-Sensing
2014-02-18 Malfunction None Adverse Event Without Identified Device or Use Problem
2014-02-14 Malfunction None Pacemaker Found in Back-Up Mode
2014-02-11 Malfunction None Failure to Interrogate, Device Displays Incorrect Message
2014-02-10 Malfunction None Device Displays Incorrect Message
2014-02-05 Injury None Communication or Transmission Problem, Device Operates Differently Than Expected
2014-02-04 Malfunction None Over-Sensing
2014-01-31 Malfunction None Under-Sensing
2014-01-30 Malfunction None Device Operates Differently Than Expected
2014-01-24 Malfunction None Difficult to Interrogate, Device Displays Incorrect Message
2014-01-24 Malfunction None Sensing Intermittently
2014-01-23 Malfunction None Pacemaker Found in Back-Up Mode
2014-01-23 Malfunction None Under-Sensing
2014-01-22 Malfunction None Sensing Intermittently, Under-Sensing
2014-01-21 Injury None Over-Sensing
2014-01-21 Malfunction None Under-Sensing
2014-01-20 Malfunction None Failure to Interrogate, Device Displays Incorrect Message
2014-01-20 Malfunction None Sensing Intermittently, Under-Sensing
2014-01-16 Malfunction None Sensing Intermittently, Under-Sensing
2014-01-14 Malfunction None Under-Sensing
2014-01-14 Injury None Failure to Interrogate, Pacemaker Found in Back-Up Mode
2014-01-12 Malfunction None Pacemaker Found in Back-Up Mode
2014-01-10 Malfunction None Device Operates Differently Than Expected
2014-01-09 Malfunction None Device Operates Differently Than Expected
2014-01-08 Malfunction None Pacemaker Found in Back-Up Mode
2014-01-07 Malfunction None Device Operates Differently Than Expected
2014-01-06 Malfunction None Device Displays Incorrect Message
2014-01-02 Malfunction None Device Operates Differently Than Expected
2014-01-02 Malfunction None Sensing Intermittently, Under-Sensing
2013-12-23 Malfunction None Pacemaker Found in Back-Up Mode
2013-12-20 Malfunction None Pacemaker Found in Back-Up Mode
2013-12-17 Malfunction None Sensing Intermittently, Under-Sensing
2013-12-16 Malfunction None Device Operates Differently Than Expected
2013-12-16 Malfunction None Failure to Interrogate
2013-12-16 Malfunction None Pacemaker Found in Back-Up Mode
2013-12-13 Malfunction None Under-Sensing
2013-12-13 Malfunction None Under-Sensing
2013-12-13 Malfunction None Under-Sensing
2013-12-13 Malfunction None Premature Elective Replacement Indicator
2013-12-13 Malfunction None Failure to Interrogate
2013-12-13 Injury None Device Operates Differently Than Expected
2013-12-11 Malfunction None Over-Sensing
2013-12-11 Malfunction None Device Operates Differently Than Expected
2013-12-11 Malfunction None Pacemaker Found in Back-Up Mode
2013-12-10 Malfunction None Failure to Interrogate
2013-12-10 Injury None Device Operates Differently Than Expected
2013-12-09 Malfunction None Sensing Intermittently, Under-Sensing
2013-12-06 Malfunction None Device Displays Incorrect Message
2013-12-05 Malfunction None Pacemaker Found in Back-Up Mode
2013-12-05 Injury None Adverse Event Without Identified Device or Use Problem
2013-12-04 Injury None Pacemaker Found in Back-Up Mode
2013-12-04 Malfunction None Pacemaker Found in Back-Up Mode
2013-11-28 Injury None Pacemaker Found in Back-Up Mode
2013-11-27 Injury None Pacemaker Found in Back-Up Mode
2013-11-26 Malfunction None Incorrect Measurement
2013-11-26 Malfunction None Sensing Intermittently, Under-Sensing
2013-11-26 Malfunction None Over-Sensing
2013-11-25 Malfunction None Sensing Intermittently, Under-Sensing
2013-11-25 Malfunction None Pacemaker Found in Back-Up Mode, Device Displays Incorrect Message
2013-11-22 Malfunction None Failure to Interrogate
2013-11-22 Injury None Pacemaker Found in Back-Up Mode
2013-11-20 Malfunction None Pacemaker Found in Back-Up Mode
2013-11-20 Injury None Under-Sensing
2013-11-19 Malfunction None Pacemaker Found in Back-Up Mode
2013-11-18 Malfunction None Device Operates Differently Than Expected
2013-11-15 Malfunction None Sensing Intermittently, Under-Sensing
2013-11-14 Malfunction None Device Operates Differently Than Expected
2013-11-14 Malfunction None Failure to Interrogate
2013-11-13 Malfunction None Pacemaker Found in Back-Up Mode
2013-11-13 Malfunction None Sensing Intermittently, Under-Sensing
2013-11-01 Malfunction None Sensing Intermittently, Under-Sensing
2013-11-01 Injury None Failure to Interrogate, Pacemaker Found in Back-Up Mode, Device Operates Differently Than Expected
2013-10-31 Malfunction None Pacemaker Found in Back-Up Mode
2013-10-31 Injury None Failure to Interrogate, Pacemaker Found in Back-Up Mode, Device Displays Incorrect Message
2013-10-29 Injury None Failure to Interrogate
2013-10-28 Malfunction None Device Displays Incorrect Message
2013-10-28 Malfunction None Pacemaker Found in Back-Up Mode
2013-10-28 Malfunction None Pacemaker Found in Back-Up Mode
2013-10-25 Malfunction None Device Displays Incorrect Message
2013-10-22 Malfunction None Pacemaker Found in Back-Up Mode
2013-10-18 Malfunction None Under-Sensing
2013-10-16 Malfunction None Pacemaker Found in Back-Up Mode
2013-10-11 Injury None Device Displays Incorrect Message
2013-10-11 Malfunction None Over-Sensing, Sensing Intermittently, Under-Sensing
2013-10-11 Injury None Failure to Interrogate, Pacemaker Found in Back-Up Mode
2013-10-07 Malfunction None Over-Sensing, Sensing Intermittently, Under-Sensing
2013-10-04 Malfunction None Electromagnetic Interference, Under-Sensing
2013-10-02 Malfunction None Pacemaker Found in Back-Up Mode
2013-10-01 Injury None Premature Discharge of Battery, Failure to Interrogate, Pacemaker Found in Back-Up Mode
2013-09-26 Malfunction None None
2013-09-26 Injury None None
2013-09-26 Malfunction None None
2013-09-26 Malfunction None None
2013-09-25 Malfunction None None
2013-09-20 Malfunction None None
2013-09-20 Malfunction None None
2013-09-19 Malfunction None None
2013-09-18 Malfunction None None
2013-09-16 Malfunction None None
2013-09-13 Malfunction None None
2013-09-12 Malfunction None None
2013-09-06 Injury None None
2013-09-04 Malfunction None None
2013-09-03 Injury None None
2013-09-03 Malfunction None None
2013-09-03 Malfunction None None
2013-08-28 Injury None Failure to Interrogate, Device Displays Incorrect Message
2013-08-28 Malfunction None None
2013-08-27 Malfunction None None
2013-08-26 Malfunction None None
2013-08-26 Injury None None
2013-08-20 Malfunction None None
2013-08-19 Malfunction None None
2013-08-19 Malfunction None None
2013-08-15 Malfunction None None
2013-08-12 Malfunction None None
2013-08-10 Malfunction None None
2013-08-09 Malfunction None None
2013-08-07 Injury None None
2013-08-07 Malfunction None None
2013-08-01 Malfunction None None
2013-08-01 Malfunction None None
2013-07-31 Malfunction None None
2013-07-30 Malfunction None None
2013-07-29 Malfunction None None
2013-07-26 Injury None None
2013-07-24 Injury None Failure to Interrogate
2013-07-22 Malfunction None None
2013-07-18 Malfunction None None
2013-07-16 Malfunction None None
2013-07-16 Malfunction None None
2013-07-15 Malfunction None None
2013-07-13 Malfunction None None
2013-07-12 Malfunction None None
2013-07-10 Malfunction None None
2013-07-08 Malfunction None None
2013-07-05 Malfunction None None
2013-07-02 Injury None None
2013-07-02 Injury None None
2013-07-01 Injury None None
2013-07-01 Injury None None
2013-06-28 Malfunction None None
2013-06-26 Malfunction None None
2013-06-24 Malfunction None None
2013-06-20 Malfunction None None
2013-06-19 Malfunction None None
2013-06-13 Malfunction None None
2013-06-13 Malfunction None None
2013-06-13 Malfunction None None
2013-06-05 Malfunction None None
2013-06-03 Malfunction None None
2013-06-03 Injury None None
2013-05-29 Injury None None
2013-05-28 Malfunction None None
2013-05-24 Malfunction None None
2013-05-24 Malfunction None None
2013-05-21 Malfunction None None
2013-05-21 Injury None None
2013-05-20 Malfunction None None
2013-05-20 Malfunction None None
2013-05-20 Malfunction None None
2013-05-16 Malfunction None None
2013-05-13 Malfunction None None
2013-05-13 Injury None None
2013-05-10 Malfunction None None
2013-05-09 Injury None None
2013-05-08 Malfunction None None
2013-05-03 Malfunction None None
2013-04-30 Malfunction None None
2013-04-30 Malfunction None None
2013-04-29 Malfunction None None
2013-04-26 Injury None None
2013-04-25 Malfunction None None
2013-04-25 Malfunction None None
2013-04-24 Malfunction None None
2013-04-23 Injury None None
2013-04-19 Malfunction None None
2013-04-17 Malfunction None None
2013-04-15 Malfunction None None
2013-04-15 Malfunction None None
2013-04-13 Malfunction None None
2013-04-12 Malfunction None None
2013-04-11 Injury None None
2013-04-09 Malfunction None None
2013-04-08 Malfunction None None
2013-04-04 Malfunction None None
2013-04-01 Malfunction None None
2013-04-01 Malfunction None None
2013-04-01 Malfunction None None
2013-03-29 Injury None None
2013-03-27 Injury None None
2013-03-25 Malfunction None None
2013-03-25 Malfunction None None
2013-03-25 Malfunction None None
2013-03-22 Malfunction None None
2013-03-22 Malfunction None None
2013-03-21 Malfunction None None
2013-03-21 Injury None None
2013-03-20 Malfunction None None
2013-03-18 Malfunction None None
2013-03-15 Malfunction None None
2013-03-15 Malfunction None None
2013-03-14 Malfunction None None
2013-03-14 Injury None None
2013-03-14 Malfunction None None
2013-03-13 Malfunction None None
2013-03-12 Malfunction None None
2013-03-04 Malfunction None None
2013-03-01 Malfunction None None
2013-02-28 Malfunction None None
2013-02-27 Injury None None
2013-02-27 Malfunction None None
2013-02-27 Malfunction None None
2013-02-27 Malfunction None None
2013-02-21 Malfunction None None
2013-02-18 Malfunction None None
2013-02-18 Malfunction None None
2013-02-14 Malfunction None None
2013-02-14 Malfunction None None
2013-02-14 Malfunction None None
2013-02-14 Malfunction None None
2013-02-13 Malfunction None None
2013-02-11 Malfunction None Under-Sensing
2013-02-08 Malfunction None None
2013-02-05 Malfunction None None
2013-02-04 Malfunction None None
2013-01-30 Injury None None
2013-01-30 Injury None None
2013-01-16 Malfunction None Device Sensing Problem
2013-01-07 Malfunction None None
2013-01-04 Injury None None
2012-12-27 Death None None
2012-12-19 Malfunction None None
2012-12-17 Malfunction None Pacemaker Found in Back-Up Mode
2012-12-14 Malfunction None None
2012-12-10 Injury None Pacemaker Found in Back-Up Mode
2012-11-20 Malfunction None Device Operates Differently Than Expected
2012-11-19 Malfunction None Device Operates Differently Than Expected
2012-11-12 Malfunction None Pacemaker Found in Back-Up Mode
2012-11-09 Malfunction None Pacemaker Found in Back-Up Mode
2012-10-23 Malfunction None Pacemaker Found in Back-Up Mode
2012-10-19 Malfunction None Pacemaker Found in Back-Up Mode
2012-10-15 Malfunction None Failure to Interrogate, Pacemaker Found in Back-Up Mode
2012-10-08 Malfunction None Device Displays Incorrect Message
2012-09-27 Malfunction None Device Displays Incorrect Message
2012-09-17 Injury None Pacemaker Found in Back-Up Mode
2012-09-14 Injury None None
2012-08-20 Malfunction None Over-Sensing, Under-Sensing
2012-08-07 Unknown None Pacemaker Found in Back-Up Mode
2012-08-01 Injury None Pacemaker Found in Back-Up Mode
2012-07-30 Malfunction None Pacemaker Found in Back-Up Mode
2012-07-12 Injury None None
2012-06-14 Injury None None
2012-06-13 Injury None None
2012-06-08 Injury None None
2012-05-16 Injury None None
2012-04-24 Injury None Pacemaker Found in Back-Up Mode
2012-04-20 Injury None None
2012-04-12 Injury None None
2012-04-04 Malfunction None Pacemaker Found in Back-Up Mode
2012-03-21 Injury None None
2012-03-19 Malfunction None None
2012-03-14 Injury None None
2012-03-01 Injury None None
2012-02-27 Injury None None
2012-02-24 Injury None None
2012-02-20 Injury None None
2012-02-15 Injury None None
2012-02-09 Injury None None
2012-02-08 Injury None None
2012-01-26 Injury None None
2011-12-20 Malfunction None Pacemaker Found in Back-Up Mode
2011-12-14 Malfunction None Under-Sensing
2011-12-08 Injury None None
2011-12-06 Injury None None
2011-12-01 Injury None None
2011-11-23 Injury None None
2011-11-10 Injury None None
2011-11-08 Malfunction None None
2011-11-04 Injury None None
2011-10-06 Malfunction None Under-Sensing
2011-09-12 Injury None None
2011-08-26 Injury None None
2011-08-24 Malfunction None Under-Sensing
2011-08-09 Malfunction None Failure to Interrogate, Device Displays Incorrect Message
2011-08-04 Malfunction None Device Displays Incorrect Message
2011-08-01 Malfunction None Pacemaker Found in Back-Up Mode
2011-07-27 Injury None None
2011-07-26 Malfunction None Premature Elective Replacement Indicator
2011-07-25 Injury None None
2011-07-25 Malfunction None Device Displays Incorrect Message
2011-07-15 Injury None None
2011-07-11 Injury None Device Sensing Problem
2011-07-06 Malfunction None Failure to Sense
2011-06-29 Malfunction None None
2011-06-29 Injury None None
2011-06-23 Malfunction None Pacemaker Found in Back-Up Mode
2011-06-23 Injury None None
2011-06-20 Injury None None
2011-06-20 Malfunction None Device Displays Incorrect Message, Device Operates Differently Than Expected
2011-06-16 Injury None None
2011-06-16 Injury None None
2011-06-16 Injury None None
2011-06-15 Malfunction None Under-Sensing
2011-06-09 Malfunction None Over-Sensing
2011-06-09 Malfunction None Over-Sensing
2011-06-06 Injury None None
2011-06-02 Malfunction None Under-Sensing
2011-06-01 Malfunction None Under-Sensing
2011-05-31 Injury None None
2011-05-23 Malfunction None Pacemaker Found in Back-Up Mode
2011-05-10 Malfunction None Sensing Intermittently
2011-04-29 Injury None None
2011-04-26 Malfunction None Under-Sensing
2011-04-13 Injury None None
2011-04-07 Injury None None
2011-03-28 Injury None Over-Sensing, Pacemaker Found in Back-Up Mode
2010-11-29 Malfunction None None
2010-06-25 Injury None None
2010-06-25 Injury None None
2010-03-24 Injury None None
2010-02-22 Injury None None