BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN EXTERNAL STIMULATOR

    MDR report key: 4170061 · Received October 14, 2014

    Report

    Report Number
    3007566237-2014-02955
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977D160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: SCREENING DEVICE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PHYSICIAN WAS REMOVING THE TRIAL LEAD, THE LEAD FRACTURED BETWEEN ELECTRODE 1 AND 2, LEAVING THE DISTAL ELECTRODES IN THE PATIENT. THE TWO ELECTRODES WERE IDENTIFIED UNDER X-RAY AND REMOVED FROM THE PATIENT. TWO DAYS LATER ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT WAS NOT HAVING ANY ISSUES. THE ENTIRE LEAD WAS REMOVED AFTER FRACTURE WITH NO ISSUES. UPON PRODUCT RETURN WHEN THE TRIAL LEAD WAS REMOVED THE ELECTRODES 0 AND 1 BROKE OFF IN THE PATIENT. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648765 UNKNOWN EXTERNAL STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR