BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2980140 · Received February 27, 2013

    Report

    Report Number
    3004209178-2013-03102
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    February 5, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# V188963, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4). ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR REVEALED NO ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THEIR DEVICE EXPLANTED. IT WAS FURTHER REPORTED THAT THE DEVICE HAD "STOPPED WORKING AFTER 1.5 YEARS." THE PATIENT WAS REPORTED TO HAVE "RECOVERED WITHOUT SEQUELAE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85378 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention