BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3850690 · Received May 21, 2014

    Report

    Report Number
    1627487-2014-02350
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 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 PATIENT'S MEDICAL HISTORY AN 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

    IT WAS REPORTED SHORTLY AFTER THE PATIENT'S IMPLANT SURGERY ON (B)(6) 2014, SHE HAD ADEQUATE STIMULATION COVERAGE, BUT COVERAGE OF THE LEFT SIDE HAS GRADUALLY DIMINISHED. THE PATIENT IS NOW HAVING INEFFECTIVE STIMULATION AND INADEQUATE PAIN RELIEF FROM HER SCS SYSTEM. AN SJM REPRESENTATIVE HAS MET WITH THE PATIENT TO ATTEMPT REPROGRAMMING, BUT WAS UNSUCCESSFUL IN ACHIEVING FULL COVERAGE IN ALL AREAS NEEDED. SURGICAL INTERVENTION IS PLANNED FOR A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304051 PENTA SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 4387138

    Patients

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