BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2834697 · Received November 16, 2012

    Report

    Report Number
    3004209178-2012-10357
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Report Date
    October 18, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-28 LOT# V922002, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PHYSICIAN WAS READING GREATER THAN 4000 OHMS ON SOME OF THE BIPOLAR PAIRS, C0, 01, 02, AND 03, AND THE OTHER IMPEDANCES WERE GOOD. THE PATIENT WAS PROGRAMMED FOR 1-,3+. THE PATIENT'S THERAPY WAS GOOD. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1