BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3484205 · Received November 22, 2013

    Report

    Report Number
    3004209178-2013-21319
    Event Type
    Malfunction
    Date Received
    November 22, 2013
    Report Date
    November 1, 2013
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3093-33, LOT# V871804, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STARTING ABOUT TWO MONTHS AGO, THE PATIENT STARTED HAVING EPISODES OF LEAKAGE OR URINE AFTER GETTING OUT OF BED. IT WAS ADDED THAT THE IMPLANTABLE NEUROSTIMULATOR HAD MOVED FROM WHERE IT WAS LOCATED NEAR THE INCISION SITE. THE PATIENT USED TO FEEL THE ¿LEADS¿ AND NOW SHE DID NOT. THE PATIENT COULD NOT ADJUST ABOVE 2.7V ON GROUP 1 AS THEY WERE GETTING THE ¿UPPER LIMIT¿ SCREEN. NO ADDITIONAL PROGRAMS WERE AVAILABLE TO THE PATIENT. ABOUT TWO WEEKS LATER, IT WAS REPORTED, THE PATIENT HAD EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND HAD NO STIMULATION SENSATION. IT WAS STATED THAT IT ¿STOPPED WORKING¿ ABOUT 4-6 MONTHS PRIOR. AT FIRST IT WAS WORKING JUST FINE FOR A WHILE AND THEN ¿ALL OF A SUDDEN IT JUST QUIT.¿ THE PATIENT WAS WEARING PADS AT NIGHT AND COULD NOT MAKE IT TO THE BATHROOM. THE PATIENT HAD FELT STIMULATION ¿ONLY FOR A WHILE¿ AFTER IMPLANT. THE PATIENT WAS NOT SURE IF IT WAS WORKING ANYMORE BECAUSE ¿IT DIDN¿T FEEL LIKE IT.¿ THE PATIENT WAS AGAIN UNABLE TO ADJUST STIMULATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610946 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1