BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC

    MDR report key: 3925785 · Received June 17, 2014

    Report

    Report Number
    1627487-2014-15469
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2014-15470. THE PT HAS 2 SCS SYSTEMS IMPLANTED. IT WAS REPORTED THE PT EXPERIENCES DISCOMFORT AT BOTH IPG SITES DUE TO THEIR LOCATION. BOTH IPGS ARE IMPLANTED IN THE PT'S BUTTOCKS AT HIS BELT LINE. THE PT STATED WHEN HE WEARS PANTS, HE FEELS BOTH IPGS MOVE IN THE POCKET AND THE AREA AROUND THE IPGS. THE PT IS TO CONSULT WITH HIS PHYSICIAN AS THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355934 EONC SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3688 4038822

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other SCS LEAD: MODEL 3228| SCS LEAD: MODEL 3228| IMPLANTED:| IMPLANTED: