BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2474801 · Received March 1, 2012

    Report

    Report Number
    3004209178-2012-01307
    Event Type
    Malfunction
    Date Received
    March 1, 2012
    Report Date
    February 8, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD: MODEL # 3889-28, LOT # V802377, IMPLANTED: (B)(6) 2011, EXPLANTED: UNKNOWN; PROGRAMMER: MODEL # 3037, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT. IT "WON'T WORK" ALSO NOTED WAS STIMULATION IN THE WRONG LOCATION; FEELING STIM IN RECTUM AREA. ALSO NOTED WAS NO STIMULATION SENSATION. IF STIM IS TOO LOW THE PATIENT DID NOT FEEL ANYTHING; IF STIM IS TOO HIGH SHE FELT IT IN THE RECTUM AREA. THE ISSUE OCCURRED FOLLOWING A FALL. THE PATIENT FELL 12/6 AND BROKE HER NOSE. THE PATIENT WENT TO URGENT CARE 2/3 AND HAD AN X RAY DONE. HEALTHCARE PROVIDER AT URGENT CARE SAID EVERYTHING LOOKED INTACT. THE HEALTHCARE PROVIDER FOLLOWING FOR INS DID NOT SEE THE XRAY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1