BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2183692 · Received July 8, 2011

    Report

    Report Number
    3004209178-2011-05245
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    January 1, 2010
    Report Date
    June 15, 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
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    HIGH IMPEDANCES (.4000 OHMS) WERE REPORTED ON ALL BIPOLAR PAIRS. IMPEDANCES AT 1.0V AND PW OF 210 WERE AS FOLLOWS: C-1=1112, C-1=1087, C-2=1122, C-3=1087 WITH ALL BIPOLAR PAIRS >4000. IMPEDANCES WERE CHECKED PREVIOUSLY IN NOVEMBER 2010 AT 1.0V AND PW OF 210 AND WERE AS FOLLOWS: 0-1=>4000, 0-2=>4000, 0-3=>4000, 1-2=>4000. AT THAT TIME 1-3 AND 2-3 WERE NORMAL. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED A LACK OF THERAPEUTIC EFFECT WHEN STIMULATION WAS TURNED ON. THE PATIENT WAS UNABLE TO FEEL STIMULATION. THE DEVICE WAS OFF WHEN THE PATIENT ARRIVED AT HER PHYSICIAN'S OFFICE. THE PATIENT HAD ADJUSTED HER STIMULATION SEVERAL MONTHS PRIOR, AND THE HEALTH CARE PROVIDER THOUGHT THE PATIENT MAY HAVE ACCIDENTALLY TURNED THE DEVICE OFF. THE PATIENT HAD BEEN HAVING A LOSS OF THERAPEUTIC EFFECT FOR THE PAST YEAR. THE BATTERY VOLTAGE APPEARED TO BE OKAY WITH A LONGEVITY OF 28 TO 47.6 MONTHS.

    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 68 YR LEAD: MODEL 3889, LOT # V434032| IMPLANT DATE:| PROGRAMMER: MODEL 3037, LOT #NJD107580N