BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3002053 · Received March 13, 2013

    Report

    Report Number
    3007566237-2013-00764
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    November 19, 2012
    Report Date
    December 19, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4). ANALYSIS OF THE LEAD FOUND THAT THE CONDUCTOR BODY WAS BROKEN AT OR NEAR THE TINES. THE #0 CONDUCTOR WAS BROKEN 5.3 CM FROM THE DISTAL END.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD MALFUNCTIONED. IT WAS EXPLANTED AND REPLACED WITH A DIFFERENT LEAD AND EXTENSION. PATIENT OUTCOME WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT'S SACRAL NERVE STIMULATOR LEAD AND EXTENSION WERE REMOVED AND REPLACED. IT WAS STATED THE CAUSE OF THE EVENT WAS A BROKEN LEAD AND THE PATIENT HAD SIDE EFFECTS "SUGGESTING A BREAK IN THE LEAD." IT WAS ALSO STATED THE REMOVED LEAD WAS "INTACT GROSSLY" AND THE NEW REPLACEMENT LEAD GAVE "GOOD RESPONSES IN FOUR POSITIONS." IT WAS NOTED THE NEW LEAD THEN WOULD FIT INTO THE OLD EXTENSION BUT "THE (UNKNOWN WORD) AND PLASTIC COVERING OVER THE TOP WOULD NOT FIT APPROPRIATELY" SO A NEW, REPLACEMENT EXTENSION WAS USED. IMPEDANCES WERE THEN TEST AND ALL WERE NORMAL. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104659 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention