BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2172374 · Received June 23, 2011

    Report

    Report Number
    3004209178-2011-04757
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 27, 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

    IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCE READINGS AT THE TIME OF IMPLANT. THE PHYSICIAN TRIED REINSERTING THE LEAD, BUT IMPEDANCE WAS STILL >4000 OHMS. THE IMPLANTED NEUROSTIMULATOR WAS REMOVED AND REPLACED WITH A DIFFERENT DEVICE. IMPEDANCE READINGS WERE WITHIN ACCEPTABLE LIMITS WITH THE NEW DEVICE. THE 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 73 YR IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD127781N| LEAD: MODEL 3093, LOT# V698093| EXPLANTED: