BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3954928 · Received July 16, 2014

    Report

    Report Number
    1627487-2014-02500
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 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 INFORMATION 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 WAS IN A CAR ACCIDENT AND SINCE HIS SCS STIMULATION HAS BECOME INEFFECTIVE. REPROGRAMMING ATTEMPTS HAVE BEEN UNSUCCESSFUL IN REGAINING EFFECTIVE STIMULATION. SURGICAL INTERVENTION IS PLANNED FOR A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416237 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3546974

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other IMPLANT DATE:| SCS IPG, MODEL 3788