BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRODE LEAD WIDE SPACED, 60 CM

    MDR report key: 2180646 · Received May 5, 2011

    Report

    Report Number
    1627487-2011-00599
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    GZB
    PMA / PMN Number
    K072462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    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

    DEVICE 1 OF 3. REFERENCE MFR. REPORT # 1627487-2011-00600 AND 1627487-2011-00601. THE PT REC'D AN SCS SYSTEM INCLUDING FOUR PERCUTANEOUS LEAD FROM THREE DIFFERENT LOTS. IT WAS REPORTED THAT THE PT IS WITHOUT STIMULATION AND UNABLE TO INCREASE THE AMPLITUDE ON ANY OF HER 15 PROGRAMS. F/U ON THIS MATTER FOUND THAT EFFECTIVE STIMULATION WAS RECAPTURED FOR THE PT VIA REPROGRAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE LEAD WIDE SPACED, 60 CM SPINAL CORD STIMULATION LEAD GZB ST JUDE MEDICAL - NEUROMODULATION DIVISION 3166 3179644

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention