BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1981607 · Received January 31, 2011

    Report

    Report Number
    3004209178-2011-00726
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    July 1, 2010
    Report Date
    January 21, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING BOWEL PROBLEMS (CONSTIPATION) AND THE DEVICE WAS SHOCKING HER WHILE THE NEUROSTIMULATOR WAS TURNED ON. THE PT HAD BEEN UNDERGOING CANCER TREATMENT AND WAS ON DIFFERENT PAIN MEDICATIONS. ALSO, FOR THE PAST COUPLE OF MONTHS, THE PT HAD BEEN DEALING WITH BLADDER INFECTIONS AND HAD BEEN ON DIFFERENT ANTIBIOTICS. PRIOR TO THE SHOCKING COMPLAINT, THE PT HAD COMPLAINTS OF NO STIMULATION SENSATION AND NEVER HAVING THERAPEUTIC EFFECT. ADD'L INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR IMPLANTED:| LEAD: MODEL 3889, LOT# V399339| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD100567N