BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENEW SINGLE RECEIVER

    MDR report key: 1960448 · Received December 16, 2010

    Report

    Report Number
    1627487-2010-03835
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    K992946
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 THAT THE PT FELT APPROX TEN MINS OF STIMULATION, AND THEN THE STIMULATOR TURNED OFF. A SJM REP MET WITH THE PT, BUT VARIOUS TROUBLESHOOTING STEPS WERE NOT SUCCESSFUL. F/U ON THE PT FOUND THAT THE PT IS SCHEDULED TO SEE HER PHYSICIAN FOR AN X-RAY OF THE SYS AND TO DISCUSS THE NEXT COURSE OF ACTION. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENEW SINGLE RECEIVER SPINAL CORD STIMULATION RECEIVER LGW ST JUDE MEDICAL - NEUROMODULATION DIV. 3416 183001B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention