BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESIS 8-CHANNEL RECHARGEABLE IPG

    MDR report key: 2151479 · Received June 21, 2011

    Report

    Report Number
    1627487-2011-03113
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 20, 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

    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 PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT RECEIVED A SCS SYSTEM ALONG WITH SURGICAL LEADS ON (B)(6) 2002. IT WAS REPORTED THAT THE PT LAST HAD STIMULATION ON (B)(6) 2011. THE PROGRAMMER WOULD NOT COMMUNICATE WITH THE IPG, AND THE PT IS UNABLE TO USE HER MAGNET TO INITIATE STIMULATION. A NEW PROGRAMMER WAND AND CHARGING SYSTEM WERE USED TO HELP RESOLVE THIS MATTER. HOWEVER, F/U ON THIS ISSUE FOUND THAT COMMUNICATION WITH THE PT'S IPG COULD NOT BE ESTABLISHED WITH THE NEW CHARGING SYSTEM. THE NEXT COURSE OF ACTION IN THIS MATTER HAS NOT BEEN DECIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS 8-CHANNEL RECHARGEABLE IPG TOTAL IMPLANTATION PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3608 139741A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention IMPLANT:| SCS LEAD: MODEL 3186 (2)