BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2152175 · Received June 23, 2011

    Report

    Report Number
    3004209178-2011-04717
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 26, 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
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND NO STIMULATION SENSATION. SHE NOTED THAT SHE FALLS OUT OF BED REGULARLY. ADDITIONAL INFORMATION INDICATED THE PT WAS STILL HAVING CONCERNS WITH HER DEVICE OR THERAPY BUT HAD NOT SOUGHT FURTHER HELP. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED INDICATED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) HAS NOT WORKED IN TWO YEARS. THE PATIENT WAS SCHEDULED TO HAVE HER INS CHECKED, BUT FAMILY MATTERS GOT IN THE WAY. THE PATIENT INTENDED TO SCHEDULE ANOTHER CHECKUP AND HAVE THE DEVICE REMOVED IF IT WAS FOUND NOT TO BE WORKING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD WETTING EPISODES SINCE TWO YEARS PRIOR. THE DEVICE HAD 'STOPPED WORKING 2 YEARS AGO.' THE PATIENT HAD NOT FOLLOWED UP WITH A HEALTH CARE PROVIDER REGARDING THE ISSUE.

    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., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD067672N| IMPLANTED:| LEAD: MODEL 3093, LOT# V096360