BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2871913 · Received December 13, 2012

    Report

    Report Number
    3004209178-2012-11798
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Report Date
    November 21, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_PROG, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 3889-28, LOT # VA00C1W, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL THE OTHER NIGHT AND "SOMETHING HAPPENED." THE PATIENT WAS IN A LOT OF PAIN AND IT WAS "COMING FROM THE DEVICE." IT WAS STATED THAT THE DEVICE "WAS ABOUT TO KILL THE PATIENT" AT THAT MOMENT AND IT FELT LIKE SOMETHING WAS "STICKING IN THE PATIENT BACK THERE." IT WAS INDICATED THAT THE PATIENT NEEDED TO TURN HER IMPLANTABLE NEUROSTIMULATOR (INS) OFF AND THEN ADDRESS THE INJURY WITH HER HEALTHCARE PROVIDER (HCP). IT WAS ALSO REPORTED THAT THE PATIENT WAS UNABLE TO MAKE ADJUSTMENTS WITH HER PATIENT PROGRAMMER WITH OR WITHOUT THE ANTENNA ATTACHED. IT WAS UNCLEAR AT THAT POINT IF THIS WAS DUE TO THE PROGRAMMER OR THE INS BECAUSE OF THE FALL. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1