BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2981493 · Received February 27, 2013

    Report

    Report Number
    3004209178-2013-03131
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    February 7, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28, LOT# V289345, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPEDANCE MEASUREMENT FOR THE NUMBER 1 ELECTRODE WAS READING GREATER THAN 4000 OHMS (C1, 01, 12, 13), WHICH AFFECTED BOTH UNIPOLAR AND BIPOLAR. THERE WERE NO FALLS OR TRAUMA REPORTED. THE PATIENT WAS IN THE PHYSICIAN'S OFFICE GETTING THE BATTERY CHECKED AND MENTIONED IT WAS WORKING AS WELL AS BEFORE. IT WAS NOTED THAT THE PATIENT WAS NOT PROGRAMMED TO THE NUMBER 1 ELECTRODE; THE PATIENT'S CURRENT CONFIGURATION WAS 02. ADDITIONAL INFORMATION WAS REQUESTED AND WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84751 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1