BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTALBE NEUROSTIMULATOR

    MDR report key: 2831338 · Received November 14, 2012

    Report

    Report Number
    3007566237-2012-02705
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# VA01HA5, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STAGE 1, TRIAL PROCEDURE, THE LEAD WAS PROPERLY PLACED INTO THE PATIENT AND REMOVED SEVERAL TIMES. EACH TIME THE LEAD WAS PLACED, AN INVOLUNTARY MOTOR RESPONSE COULD NOT BE PRODUCED FROM THE PATIENT. THE TEST CABLE, GROUNDING PADS, AND TEST STIMULATOR WERE REPLACED BUT IT DID NOT CORRECT THE PROBLEM. THE LEAD WAS REPLACED AND THE NEW LEAD WORKED PROPERLY ONCE IMPLANTED. THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THE EVENT. THE PATIENT'S STATUS AT THE TIME OF REPORT WAS NOTED AS 'NO INJURY/NO ADVERSE EVENT.'

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR