BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS XP 8-CHANNEL RECHARGEABLE IPG

    MDR report key: 2190992 · Received July 29, 2011

    Report

    Report Number
    1627487-2011-07010
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 28, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 A SCS SYSTEM ON (B)(6) 2007. IT WAS REPORTED ON (B)(6) 2011 THAT THE PATIENT HAD NOT HAD STIMULATION FOR AT LEAST 2 YEARS. THE PROGRAMMER WAS LOST. PATIENT COULD NOT REMEMBER ANY DETAILS OTHER THAN SHE HAD GOOD STIMULATION BEFORE THEN ONE DAY IT JUST SHUT OFF. NO PROGRAM PARAMETERS WERE AVAILABLE. THE 3609 IPG WAS REPLACED WITH AN EON IPG AND THE STIMULATION WAS TURNED BACK ON. THE FACILITY WILL NOT RELEASE THE IPG. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS XP 8-CHANNEL RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3609 48192

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention IMPLANTED:| IMPLANTED:| SCS LEAD: MODEL 3245| SCS LEAD: MODEL 3189 (2)