BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3960438 · Received July 17, 2014

    Report

    Report Number
    1627487-2014-15547
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    March 31, 2014
    Report Date
    June 24, 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
    AZ, 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

    THE PT REPORTED, HE WAS UNABLE TO FEEL STIMULATION EVEN AFTER INCREASING THE AMPLITUDE. THE SJM REPRESENTATIVE MET WITH THE PT AND DIAGNOSTIC TESTING INDICATES INVALID IMPEDANCE READINGS. REPROGRAMMING WAS INITIALLY ABLE TO PROVIDE EFFECTIVE COVERAGE. HOWEVER, THE ISSUE REOCCURRED AND ADDITIONAL REPROGRAMMING WAS UNABLE TO PROVIDE EFFECTIVE COVERAGE. X-RAYS WERE TAKEN AND DID NOT REVEAL ANY ANOMALIES. THE PT HAS YET TO DECIDE IF HE WANTS TO UNDERGO SURGICAL INTERVENTION FOR THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420449 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3315571

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other SCS IPG: MODEL 3788| IMPLANT DATE: