PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR

SCS IPG

This device is manufactured by ABBOTT MEDICAL, ABBOTT MEDICAL / ST JUDE MEDICAL, ST JUDE / ABBOTT MEDICAL, ST JUDE MEDICAL, ST JUDE MEDICAL - NEUROMODULATION and others.

The following problems were reported about this device:

Year Description Events/year Type
2024 Wound Dehiscence 1 Patient
2024 Unspecified Infection 2 Patient
2024 Undesired Nerve Stimulation 1 Patient
2024 Insufficient Information 11 Patient
2024 Inadequate Pain Relief 63 Patient
2024 Implant Pain 24 Patient
2024 Fluid Discharge 1 Patient
2024 Failure of Implant 69 Patient
2024 Erosion 1 Patient
2024 Wireless Communication Problem 25 Device
2024 Unexpected Shutdown 1 Device
2024 Therapeutic or Diagnostic Output Failure 2 Device
2024 No Apparent Adverse Event 1 Device
2024 Migration 3 Device
2024 Insufficient Information 10 Device
2024 Delayed Alarm 1 Device
2024 Battery Problem 33 Device
2024 Adverse Event Without Identified Device or Use Problem 21 Device
2023 Unspecified Infection 5 Patient
2023 Undesired Nerve Stimulation 2 Patient
2023 Pocket Erosion 2 Patient
2023 Pain 1 Patient
2023 Myocardial Infarction 1 Patient
2023 Insufficient Information 10 Patient
2023 Inadequate Pain Relief 103 Patient
2023 Implant Pain 50 Patient
2023 Failure of Implant 62 Patient
2023 Cramp(s) /Muscle Spasm(s) 1 Patient
2023 Burning Sensation 1 Patient
2023 Bruise/Contusion 1 Patient
2023 Abdominal Cramps 1 Patient
2023 Wireless Communication Problem 47 Device
2023 Temperature Problem 1 Device
2023 Premature Elective Replacement Indicator 1 Device
2023 Pocket Stimulation 2 Device
2023 No Apparent Adverse Event 5 Device
2023 Migration 7 Device
2023 Insufficient Information 11 Device
2023 Incomplete or Inadequate Connection 1 Device
2023 Inappropriate/Inadequate Shock/Stimulation 1 Device
2023 Failure to Advance 1 Device
2023 Communication or Transmission Problem 1 Device
2023 Battery Problem 63 Device
2023 Application Program Freezes, Becomes Nonfunctional 2 Device
2023 Adverse Event Without Identified Device or Use Problem 56 Device
2022 Unspecified Infection 1 Patient
2022 Swelling/ Edema 1 Patient
2022 Post Operative Wound Infection 1 Patient
2022 Inadequate Pain Relief 25 Patient
2022 Implant Pain 5 Patient
2022 Hypersensitivity/Allergic reaction 1 Patient
2022 Fluid Discharge 1 Patient
2022 Failure of Implant 8 Patient
2022 Erosion 1 Patient
2022 Wireless Communication Problem 51 Device
2022 Unexpected Shutdown 1 Device
2022 Temperature Problem 1 Device
2022 Separation Failure 1 Device
2022 Premature Elective Replacement Indicator 4 Device
2022 Premature Discharge of Battery 1 Device
2022 No Apparent Adverse Event 5 Device
2022 Migration 7 Device
2022 Low impedance 1 Device
2022 Insufficient Information 3 Device
2022 Impedance Problem 2 Device
2022 High impedance 4 Device
2022 Battery Problem: High Impedance 1 Device
2022 Battery Problem 81 Device
2022 Adverse Event Without Identified Device or Use Problem 44 Device
2021 Inadequate Pain Relief 6 Patient
2021 Failure of Implant 6 Patient
2021 Erosion 1 Patient
2021 Discomfort 1 Patient
2021 Wireless Communication Problem 12 Device
2021 Premature Elective Replacement Indicator 2 Device
2021 Migration 1 Device
2021 Insufficient Information 1 Device
2021 Battery Problem 2 Device
2021 Application Program Freezes, Becomes Nonfunctional 1 Device
2020 Inadequate Pain Relief 4 Patient
2020 Implant Pain 1 Patient
2020 Failure of Implant 3 Patient
2020 Wireless Communication Problem 3 Device
2020 Premature Elective Replacement Indicator 1 Device
2020 Communication or Transmission Problem 1 Device
2020 Battery Problem 4 Device
2020 Adverse Event Without Identified Device or Use Problem 2 Device