BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESISRC IMPLANTABLE PULSE GENERATOR

    MDR report key: 1895465 · Received November 4, 2010

    Report

    Report Number
    1627487-2010-03504
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 11, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'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 BATTERY DEPLETION. THE EXPLANTED IPG WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. F/U ON THE PT 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention