BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2181453 · Received July 6, 2011

    Report

    Report Number
    3004209178-2011-05145
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. STIMULATION WAS INCREASED ON THE EVENING OF (B)(6) 2011; THE (B)(6), THE PATIENT EXPERIENCED LOSS OF BLADDER CONTROL AND COULD NOT FEEL STIMULATION. STIMULATION HAD PREVIOUSLY WORKED WELL FOR THE PATIENT. THE PATIENT WAS UNABLE TO INTERROGATE THE IMPLANTED NEUROSTIMULATOR WITH OR WITHOUT THE ANTENNA; THEREFORE, IT COULD NOT BE CONFIRMED WHETHER THE DEVICE WAS ON. A POOR COMMUNICATION SCREEN WAS DISPLAYED. 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 EZW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD127195N| LEAD: MODEL 3093, LOT# V686370