BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2990963 · Received March 6, 2013

    Report

    Report Number
    3004209178-2013-03365
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    September 12, 2007
    Report Date
    February 13, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3889-28 LOT# V048745, IMPLANTED: 2007 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3095-10 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. IT WAS STATED THAT THE "DEVICE STOPPED WORKING AND THAT THE THERAPY NEVER REALLY WORKED SINCE IMPLANT. REPORTEDLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS KNOWN AT THE TIME OF REPORT. IF ADDITIONAL INFORMATION WAS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96070 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention