BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2628352 · Received June 26, 2012

    Report

    Report Number
    3004209178-2012-04853
    Event Type
    Malfunction
    Date Received
    June 26, 2012
    Report Date
    May 30, 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
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LEAD: MODEL 3889-28, LOT# V223166, IMPLANTED: (B)(6) 2009, EXPLANTED: NA. PROGRAMMER: MODEL 3037, SERIAL# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RETURN OF SYMPTOMS AND LOST STIMULATION SENSATION. THE PATIENT WAS UNABLE TO COMMUNICATE WITH THE NEUROSTIMULATOR, THOUGH THE POCKET LOOKED VISUALLY GOOD. IT WAS DETERMINED THAT THE BATTERY WAS DEPLETED. BASED ON THE SETTINGS THE DEPLETION APPEARED TO OCCUR FASTER THAN THE ESTIMATE. IT WAS NOTED THAT PRIOR TO DEVICE DEPLETION, THERAPY WAS GREAT AND THE PATIENT WAS FEELING STIMULATION. 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