BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENESIS IPG

    MDR report key: 2222537 · Received August 11, 2011

    Report

    Report Number
    1627487-2011-02913
    Event Type
    Other
    Date Received
    August 11, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CONCLUSION: THE LOW BATTERY WARNING WAS DUE TO PASSIVATION. 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 HIS SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT THE IPG WAS EXPLANTED AND REPLACED ON (B)(6) 2011 DUE TO BATTERY DEPLETION. THE EXPLANTED IPG WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3608 3165993

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention SCS LEAD: MODEL 3186| IMPLANT: