BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1823561 · Received August 27, 2010

    Report

    Report Number
    3004209178-2010-06521
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 29, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND NO STIMULATION SENSATION. IMPEDANCES OF >4000 OHMS WERE REPORTED ON THE UNIPOLAR PAIRS ON THE PT'S DEVICE. IT WAS ALSO NOTED THAT THE IMPEDANCES MEASUREMENTS OF <250 OHMS WERE SEEN ON THE BIPOLAR PAIRS. X-RAYS SHOWED THAT EVERYTHING WAS INTACT AND IN PLACE ALTHOUGH THE COMPANY REP COULD NOT REMEMBER THE EXACT LEAD PLACEMENT. IT WAS POSSIBLE THAT THE LEAD PULLED BACK FROM THE NEUROSTIMULATOR BUT THIS WAS NOT CONFIRMED AT THE TIME OF THIS REPORT. THERE WAS NO ACCIDENT OR INCIDENT RELATED TO THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED. SEE MANUFACTURER REPORT #3004209178-2010-06524 FOR REVISION/REPLACEMENT OF LEAD ISSUE 6 MONTHS AGO FOR LOSS OF STIMULATION OF DIFFERENT NEUROSTIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR LEAD: MODEL 3093, LOT# V379942| PROGRAMMER: MODEL 3037, LOT# NJD097797N| IMPLANTED:| EXPLANTED: