BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3143363 · Received June 3, 2013

    Report

    Report Number
    3007566237-2013-01840
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 14, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT WOKE UP THE MORNING AFTER SHE WAS IMPLANTED, IT WAS DISCOVERED THAT THE PATIENT HAD A BOWEL MOVEMENT DURING THE NIGHT AND IT WAS DIARRHEA. THE PATIENT HAD REPORTEDLY NOT HAD THIS SYMPTOM BEFORE. THE REPORTER INDICATED THAT ¿DURING EVALUATION AT FIRST STIMULATION, IT WAS MORE ON THE SIT BONES¿. THE PATIENT WAS REPROGRAMMED SO¿IT WAS MORE IN THE VAGINAL AREA¿. AT THE TIME OF THE REPORT, STIMULATION WAS ON, ON PROGRAM 1 AT .8V AND THE PATIENT FELT STIMULATION ¿INTERMITTENTLY¿ IN THE VAGINAL AREA.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT STILL HAD CONCERNS WITH THEIR DEVICE THERAPY BUT HAD NOT SOUGHT FURTHER HELP. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    INFORMATION REVIEWED INDICATED THAT PATIENT WAS INCONTINENT DURING THE NIGHT FOR BOWEL MOVEMENT. IT WAS ALSO REPORTED THAT THE RIGHT SIDE WAS VERY SORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243863 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1