BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4180895 · Received October 17, 2014

    Report

    Report Number
    3004209178-2014-19884
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    September 24, 2014
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA08EZS, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UN KNOWN_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD A FALL SIX DAYS PRIOR TO THIS CALL AND WAS DOWN FOR 8 HOURS AND NOT ABLE TO GET BACK UP. SHE STATED SHE PASSED OUT FOR THAT LONG. THE PATIENT HAS MS AND WAS IN AN INPATIENT PHYSICAL THERAPY AT THE HOSPITAL, WANTED HER BLADDER CATHETER OUT. IT WAS REPORTED THAT PATIENT WAS HAVING SOME PROBLEMS WITH THE REMOTE, WHICH WAS LATER IDENTIFIED TO BE THE NEUROSTIMULATOR (INS). THE PATIENT WENT FROM TOTAL INCONTINENCE TO NOT BEING ABLE TO GO AT ALL; ABOUT A WEEK AGO WHICH ALL HAPPENED AFTER THE FALL. IT WAS NOTED THAT THE INS WAS TURNED OFF FOR MRI. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. A FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662994 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR