BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2992149 · Received March 7, 2013

    Report

    Report Number
    3007566237-2013-00708
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    February 13, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE LEAD REVEALED THE FOLLOWING: TWO CONDUCTORS ARE BROKEN BETWEEN THE MIDDLE TWO TINES 4.0 CM FROM THE DISTAL END. ONE CONDUCTOR IS BROKEN BETWEEN THE TWO MOST PROXIMAL TINES 4.4 CM FROM THE DISTAL END. ONE CONDUCTOR IS BROKEN AT THE PROXIMAL MARKER BAND 5.1 CM FROM THE DISTAL END.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, SERIAL# UNKNOWN, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD WAS REPLACED DUE TO HAVING HIGH IMPEDANCES AND A LOSS OF STIMULATION/THERAPEUTIC EFFECT. PATIENT STATUS AT THE TIME OF THIS REPORT WAS STATED AS ALIVE WITH NO INJURY/NO ADVERSE EVENT. THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98057 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention