BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4516515 · Received February 13, 2015

    Report

    Report Number
    3004209178-2015-02988
    Event Type
    Injury
    Date Received
    February 13, 2015
    Report Date
    January 21, 2015
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3093-28, LOT# V042808, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEUROSTIMULATOR DEVICES WERE REMOVED (B)(6) 2013. NEUROSTIMULATOR DEVICE DIED OUT AND KEPT SENDING SHOCKS. IT WAS LATER REPORTED THAT THE FOLLOW UP HEALTHCARE PROVIDER WAS UNAWARE THAT THERE WAS A PROBLEM. THE CAUSE OF THE EVENT WAS NOT DETERMINED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106959 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention