BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2182354 · Received July 11, 2011

    Report

    Report Number
    3004209178-2011-05286
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    RECEIVED INFO THAT DURING SURGERY THE LEAD WAS IMPLANTED BUT WHEN IT WAS CONNECTED TO THE BATTERY, IMPEDANCE READINGS WERE > 4,000 OHMS ON NUMEROUS ELECTRODES. AMPLITUDE WAS INCREASED TO 2.5 V AND PULSE WIDTH TO 300. READINGS WERE RECHECKED SEVERAL TIMES WITH VARIOUS PARAMETERS. IMPEDANCES WERE STILL > 4,000 OHMS. THE PHYSICIAN ELECTED TO TRY A NEW INS. ONCE THE INS WAS CONNECTED AND CHECKED, IMPEDANCES WERE STILL > 4,000 OHMS ON SEVERAL ELECTRODES. PHYSICIAN DID NOT WANT TO CHANGE THE LEAD, SO THE PT WAS PROGRAMMED ON THE LEADS WITH NORMAL IMPEDANCES. IN THE RECOVERY ROOM THE IMPEDANCES WERE CHECKED AGAIN AND ALL WERE WITHIN NORMAL RANGE. PT RECOVERED WITHOUT SEQUELA.

    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 58 YR PROGRAMMER: MODEL 3037, LOT# NJD111455N| EXPLANTED:| LEAD: MODEL 3889, LOT# V673559| IMPLANTED: