BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2771712 · Received October 4, 2012

    Report

    Report Number
    3004209178-2012-08867
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    September 14, 2012
    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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V884820, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. FOR USE BY USER FACILITY/IMPORTER(DEVICES ONLY). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS FLIPPED ON ITS SIDE "LIKE A QUARTER STANDING UP." IT HAD BEEN THAT WAY FOR A COUPLE OF MONTHS. PATIENT HAD REVISION SURGERY TO FIX IT. AFTER SURGERY, THE PATIENT WAS UNABLE TO ADJUST STIMULATION. PATIENT HAD ONE PROGRAM AVAILABLE INSTEAD OF FOUR AND THE PROGRAMMER SHOWED THE UPPER LIMIT ICON IF THE PATIENT TRIED TO INCREASE THE STIMULATION FROM 0V. STIMULATION HAD BEEN OFF AND THE PATIENT TURNED IT BACK ON. AT A FOLLOW-UP APPOINTMENT THE PATIENT HAD HER IMPLANT AND PROGRAMMER RE-SYNCED AND EVERYTHING WAS WORKING FINE. THE PATIENT WAS FEELING STIMULATION IN THE BICYCLE AREA AND WAS COMFORTABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention