BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3370587 · Received September 26, 2013

    Report

    Report Number
    3004209178-2013-16993
    Event Type
    Injury
    Date Received
    September 26, 2013
    Report Date
    September 5, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V813487, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4). FINAL DEVICE ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED THE FOLLOWING: NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPEDANCE READING SHOWED DAMAGE TO ALL FOUR ELECTRODES. IT WAS STATED THE PATIENT¿S DEVICE WAS REMOVED DUE TO NORMAL BATTERY DEPLETION AND LEAD BREAKAGE. IT WAS NOTED THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487037 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention