BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SACRAL STIMULATOR

    MDR report key: 1250382 · Received December 3, 2008

    Report

    Report Number
    2182207-2008-07979
    Event Type
    Injury
    Date Received
    December 3, 2008
    Report Date
    November 6, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE : KESSLER TM, BURKHARD FC, MADERSBACHER H, KOFLER A, POEWE W, KISS G. SAFETY OF PROLONGED SACRAL NEUROMODULATION TINED LEAD TESTING. CURR MED RES OPIN. IN LATE 2007. WE PROSPECTIVELY ASSESSED THE COMPLICATIONS ASSOCIATED WITH PROLONGED TINED LEAD TESTING. REPORTABLE EVENT; ONE PATIENT WITH BILATERAL TINED LEADS COMPLAINED ABOUT REFECTORY PAIN AT THE LEFT LEAD SITE 3 DAYS AFTER SURGERY REQUIRING SURGICAL REVISION AND EXPLANTED OF THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SACRAL STIMULATOR EZW MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization PROGRAMMER, MODEL UNK N=1| LEAD: MODEL UNK N=2