BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 1861162 · Received October 4, 2010

    Report

    Report Number
    3004209178-2010-07572
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    January 1, 2010
    Report Date
    September 7, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    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

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. PT INDICATED THAT THEY WERE GOING TO HAVE THEIR LEADS REPLACED AND A REVISION SURGERY. PT HAD A DEVICE IMPLANTED FOR ABOUT FIVE YRS AND LEADS WERE IN BAD SHAPE, POSSIBLY MOVED. TWO YRS AFTER THE DEVICE WAS PUT IN, THE BATTERY WENT OUT. NUMEROUS REPROGRAMMINGS HAVE BEEN TRIED BUT THE DEVICE DOES NOT WORK LIKE IT DID WHEN IT WAS FIRST PUT IN. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR EXTENSION: MODEL 3095, LOT# NAH018698V| PROGRAMMER: MODEL 3031A, LOT# NGM017661P| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3093, LOT# J0444032V| IMPLANTED: