BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS

    MDR report key: 3850553 · Received May 29, 2014

    Report

    Report Number
    1627487-2014-10120
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    March 24, 2014
    Report Date
    May 8, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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 PT'S (B)(6) IPG STOPPED WORKING AFTER HAVING STIMULATION ON NEAR WELDING DEVICES. IN ADDITION, A "NO COMMUNICATION" ERROR MESSAGE WAS OBSERVED ON THE PT PROGRAMMER. THE PHYSICIAN ELECTED TO PROCEED WITH SURGICAL INTERVENTION TO EXPLANT AND REPLACE THE IPG WHICH RESOLVED THE REPORTED ISSUE. EFFECTIVE STIMULATION WAS RESTORED FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317249 GENESIS SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3608 4244526

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other