BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4900908 · Received July 9, 2015

    Report

    Report Number
    3007566237-2015-01915
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 18, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# VA0V239, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT ON (B)(6) 2015. THE PATIENT WAS ¿WET¿ AND WANTED TO CHANGE THEIR SETTINGS. DURING THE CALL, THE PATIENT WAS ON PROGRAM 3 AT 1.0V AND ¿DID NOT REALLY FEEL STIMULATION.¿ UPON INCREASING TO 1.2V THE PATIENT FELT STIMULATION AND WAS TO TRY THAT LEVEL OVERNIGHT. NO FURTHER INFORMATION WAS REPORTED. FURTHER FOLLOW UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447373 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR