BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2023462 · Received March 8, 2011

    Report

    Report Number
    3004209178-2011-01757
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 28, 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
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE STIMULATION WAS TURNED ON, THE PT EXPERIENCED A SHOCKING OR JOLTING SENSATION. THE PT FELL ABOUT TWO MONTHS AGO BUT SHOCKS ON THE RIGHT SIDE STARTED FOUR DAYS AGO. THE SHOCKS OCCURRED WHEN THE PT WAS SITTING. THE SHOCKS STARTED HAPPENING ABOUT TWO TIMES A DAY AND HAD GOTTEN WORSE. IT WAS ALSO NOTED THAT THERE WAS AN ISSUE WITH THE PT PROGRAMMER. THE PT WAS NOT ABLE TO ADJUST STIMULATION. THE PT PROGRAMMER WAS BLANK NO MATTER WHAT BUTTON WAS PUSHED. AFTER PUTTING IN NEW BATTERIES, THE PT WAS ABLE TO USE THE PT PROGRAMMER AND SHOCKING FROM THE INS (IMPLANTABLE NEURO STIMULATOR) STOPPED. THE BATTERIES IN THE PT PROGRAMMER ARE NOT RELATED TO STIMULATION SENSATION. THE PT WAS AT HOME AT THE TIME OF THE REPORT AND HAD AN APPOINTMENT WITH THEIR HEALTHCARE PROVIDER THE NEXT DAY. ADDITIONAL INFO WAS REQUESTED.

    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 72 YR IMPLANTED:| EXPLANTED:| LEAD: MODEL 3889, LOT # V248559| PROGRAMMER: MODEL 3037, LO5T # NJD100972N