BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3110912 · Received May 8, 2013

    Report

    Report Number
    1627487-2013-15611
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    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 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. REF MFR REPORT: 1627487-2013-15612. IT WAS REPORTED, THE PT IS NOT RECEIVING ADEQUATE PAIN RELIEF. ALSO, THE PT DOES NOT LIKE HOW THE STIMULATION FEELS. THE PT'S SCS SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200160 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3895349

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention SCS ANCHOR, MODEL 1194 (2)| IMPLANT DATE: