BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3365689 · Received September 24, 2013

    Report

    Report Number
    3004209178-2013-16860
    Event Type
    Injury
    Date Received
    September 24, 2013
    Report Date
    September 3, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28 LOT# V933654, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037 L OT# SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4). FINAL DEVICE ANALYSIS OF THE LEAD REVEALED THE FOLLOWING: NO ANOMALY FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S LEAD WAS REPLACED BECAUSE IT WAS ¿NOT WORKING.¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480864 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention