BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3961000 · Received July 22, 2014

    Report

    Report Number
    1627487-2014-24044
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    April 4, 2012
    Report Date
    July 2, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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

    THE PATIENT REPORTED THAT HE HAS EXPERIENCED BOWEL AND URINARY INCONTINENCE WITH STIMULATION SINCE IMPLANT. REPROGRAMMING HAS BEEN UNSUCCESSFUL. SURGICAL INTERVENTION WILL TAKE PLACE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429076 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3577069

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other IMPLANT DATE:| SCS IPG: MODEL 3788