BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3003879 · Received March 14, 2013

    Report

    Report Number
    3007566237-2013-00776
    Event Type
    Injury
    Date Received
    March 14, 2013
    Report Date
    February 21, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF LEAD (1 OF 2) FOUND THE STIMULATION LEAD BODY CONDUCTOR BROKEN AT OR NEAR TINES. ALL CONDUCTORS WERE BROKEN. ANALYSIS OF LEAD (2 OF 2) FOUND THE STIMULATION LEAD BODY CONDUCTOR BROKEN AT OR NEAR TINES. ALL CONDUCTORS WERE BROKEN.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3889, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED LESS THAN 50 PERCENT THERAPY RELIEF AND HIGH IMPEDANCES WERE REPORTED. IT WAS ALSO REPORTED THE PATIENT HAD THE LEADS IMPLANTED NEAR THE PUDENDUS NERVE DUE TO PELVIC PAIN. THE PATIENT WAS REPORTED TO HAVE BIKED SEVERAL TIMES BEFORE A LOSS OF THERAPY OCCURRED. IT WAS ALSO REPORTED THE PHYSICIAN TRIED TO REPROGRAM THE PATIENT'S DEVICE WITHOUT SUCCESS AND IMPEDANCE MEASUREMENTS SHOWED HIGH IMPEDANCES, GREATER THAN 4,000 OHMS. IT WAS REPORTED THE PATIENT'S LEADS WERE EXPLANTED AND DURING THE EXPLANT PROCEDURE THE LEADS WERE CUT AND THE PROXIMAL PART OF THE LEADS WERE LEFT IMPLANTED IN THE EXTENSION CONNECTOR. IT WAS ALSO REPORTED THE EXTENSION AND BATTERY WERE LEFT IMPLANTED AND THE PATIENT RECOVERED WITH NO INJURY OR ADVERSE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107607 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention