BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS

    MDR report key: 4112911 · Received September 17, 2014

    Report

    Report Number
    1627487-2014-24196
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    August 27, 2009
    Report Date
    August 27, 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
    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

    IT WAS REPORTED THE PT HAS NOT USED HER SCS SYSTEM APPROXIMATELY FIVE YEARS AGO DUE TO OVER-STIMULATION AT THE IPG SITE. AS A RESULT, THE PROGRAMMER COULD NOT ESTABLISH COMMUNICATION WITH THE IPG AS THE DEVICE IS INOPERABLE. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576042 GENESIS SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3608 4632

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other SCS LEAD: MODEL 3186| IMPLANTED: