BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 6079046 · Received November 4, 2016

    Report

    Report Number
    3004209178-2016-23240
    Event Type
    Injury
    Date Received
    November 4, 2016
    Report Date
    November 4, 2016
    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
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3093-28, LOT# V945725, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. THIS EVENT WAS ALSO PREVIOUSLY REPORTED UNDER MANUFACTURER'S REPORT #6000153-2016-00356.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM PATIENT REPORTED THAT SHE HAD THE FIRST BATTERY REMOVED AND THE NEW ONE PUT IN BECAUSE THE BATTERY WAS BAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731381 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention