BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2193296 · Received July 13, 2011

    Report

    Report Number
    3004209178-2011-05368
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 18, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT NEVER RECEIVED THERAPEUTIC EFFECT OR STIMULATION SENSATION FROM THEIR DEVICE. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS REPORT. IT WAS ALSO REPORTED THAT WHEN THE STIMULATION WAS TURNED ON THE STIMULATION WAS TURNING OFF BY ITSELF. THIS WAS POTENTIALLY THE RESULT OF GOING THROUGH A SECURITY GATE AT (B)(6). IN ORDER TO RULE OUT MISUSE OF THE PT PROGRAMMER THE PT BEGAN NOT USING THE PT PROGRAMMER AND THE DEVICE WAS ONLY TURNED ON AT THE OFFICE. THE PT WAS KEEPING A DIARY OF WHEN THE DEVICE SHUTS OFF. THE DEVICE CONTINUED TO NOT WORK PROPERLY. THE ONLY SUGGESTION WAS TO REPLACE THE BATTERY. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 67 YR EXPLANTED:| IMPLANTED:| LEAD: MODEL 3889, LOT V466243| PROGRAMMER: MODEL 3037, LOT #NJD106799N