BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESISRC IMPLANTABLE PULSE GENERATOR

    MDR report key: 1910926 · Received November 23, 2010

    Report

    Report Number
    1627487-2010-03613
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE IPG WAS RETURNED WITH SOME MINOR SURFACE SCRATCHES ON BOTH THE ANTENNA AND THE CAN. FUNCTIONAL TESTING FOUND THE BATTERY WAS VERY LOW AND REQUIRED RECHARGING PRIOR TO TESTING. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2005. IT WAS REPORTED THE IPG WAS EXPLANTED AND REPLACED DUE TO A LOSS OF STIMULATION AND SUSPECTED BATTERY DEPLETION. THE EXPLANTED IPG WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. FOLLOW UP ON THE PATIENT FOUND NO FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESISRC IMPLANTABLE PULSE GENERATOR TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3708 35259A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention