BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL NEUROSTIMULATOR

    MDR report key: 7782584 · Received August 14, 2018

    Report

    Report Number
    3007566237-2018-02424
    Event Type
    Malfunction
    Date Received
    August 14, 2018
    Date of Event
    July 11, 2018
    Report Date
    November 8, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT#: 0213698056, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3889-28, SERIAL/LOT #: (B)(4), UBD: 10-JUL-2021, UDI#: (B)(4). (B)(6). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTION: PLEASE NOTE THE PRODUCT CODE CAPTURED HAS BEEN UPDATED FROM LGW TO EZW AT THIS TIME. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD ¿NO RESPONSE¿ DURING AN ELECTROPHYSIOLOGICAL TEST PERFORMED AT THE TIME OF IMPLANT. THE CAUSE OF THE ISSUE WAS UNKNOWN. THE LEAD WAS REPLACED AS A RESULT OF THE ISSUE IN ORDER TO COMPLETE THE OPERATION. IT WAS NOTED THE LEAD REPLACEMENT WAS CONSIDERED AN EFFECTIVE MEASURE. THE PATIENT WAS IN GOOD CONDITION AT THE TIME OF REPORT; NO COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621822 EXTERNAL NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1