BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS

    MDR report key: 4201962 · Received October 17, 2014

    Report

    Report Number
    1627487-2014-25644
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 22, 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
    GM
    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

    DEVICE 1 OF 2. REFERENCE MFR. REPORT #: 1627487-2014-25645. IT WAS REPORTED THE PATIENT (B)(6) LOST STIMULATION. X-RAYS REVEALED THE EXTENSION DISCONNECTED FROM THE IPG HEADER AND A KINK IN THE LEAD. IN TURN, THE PATIENT WILL UNDERGO SURGICAL INTERVENTION AT A LATER DATE TO ADDRESS THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663341 GENESIS SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3608 4607965

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other SCS ANCHOR: MODEL 1192| IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION: MODEL 3386