BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESISRC

    MDR report key: 3962485 · Received July 14, 2014

    Report

    Report Number
    1627487-2014-00418
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    IT WAS REPORTED THE PATIENT'S ((B)(6)) IPG HAD ROTATED IN THE POCKET THEREBY MAKING IT DIFFICULT TO COMMUNICATE WITH THE DEVICE USING EITHER THE PROGRAMMER OR CHARGING SYSTEM. SURGICAL INTERVENTION WAS UNDERTAKEN WITH THE INTENT OF REPOSITIONING THE PATIENT'S IPG; HOWEVER, BOTH PREOPERATIVE AND INTRAOPERATIVE TESTING FOUND THAT NO COMMUNICATION COULD BE ESTABLISHED WITH THE DEVICE. AS SUCH, THE PATIENT'S IPG WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409668 GENESISRC SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3708 48311

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other SCS LEAD: MODEL 2243| IMPLANT DATE: