BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2191814 · Received July 22, 2011

    Report

    Report Number
    3004209178-2011-05704
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 28, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A SHOCKING OR JOLTING SENSATION AT THE LEAD LOCATION FOLLOWING A POSITION CHANGE. IT WAS UNCLEAR IF THE PT HAD CHANGED POSTURE, BUT THE PT JUST HAD BEEN TRYING TO SYNCHRONIZE THE PROGRAMMER AND THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PT WAS NOT USING THE ANTENNA. THE PT ALSO HAD PAIN AT THE INS LOCATION FOLLOWING A STRENUOUS ACTIVITY OR EXERCISE. IT WAS ALSO NOTED THAT THE PT PROGRAMMER SCREEN KEPT FLASHING. A NEW PROGRAMMER WAS SENT TO THE PT AND WAS WORKING FINE. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT WHEN ADD'L INFO BECOMES AVAILABLE.

    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 55 YR PROGRAMMER: MODEL 3037, LOT# NJD125361N| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3889, LOT# V681796