BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2183666 · Received July 8, 2011

    Report

    Report Number
    3004209178-2011-05237
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    December 22, 2010
    Report Date
    June 15, 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
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DEVICE READING OF >4000 OHMS ON SOME OF THE BIPOLAR PAIRS AND ALL OR SOME UNIPOLAR PAIRS. ALSO REPORTED PT FELT STIMULATION IN THE WRONG LOCATION 3 MONTHS AFTER IMPLANT. THERE WAS NO KNOWN ACCIDENT OR EVENT RELATED TO THIS. PT HAD TURNED OFF THE INS SINCE (B)(6) 2011. X-RAYS OF THE INS AND LEAD AREA WERE RECOMMENDED.

    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 80 YR IMPLANTED:| PROGRAMMER: MODEL 3037, NOT #NJD112856N| LEAD: MODEL 3093, LOT #V508243| EXPLANTED: