BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 1930299 · Received November 24, 2010

    Report

    Report Number
    3007566237-2010-09939
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IMPEDANCES WERE CHECKED AT IMPLANT AND FOUND TO BE GREATER THAN 10,000 OHMS ON FOUR ELECTRODES. THE LEAD WAS DISCONNECTED FROM THE EXTENSION AND STIMULATOR AND CHECKED WITH AN EXTERNAL STIMULATOR AND SNAP-LID CONNECTOR. THE IMPEDANCES WERE STILL GREATER THAN 10,000 OHMS ON ELECTRODES 4, 13, 14, AND 15. THE LEAD AND EXTENSION WERE BOTH REPLACED AND SUBSEQUENT IMPEDANCE CHECKS WERE OK. THE OUTCOME WAS REPORTED AS "STIMULATOR WORKING FINE WITH LEAD FINALLY IMPLANTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SPINAL CORD STIMULATOR LGW MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| EXPLANTED:| LEAD: MODEL 39286-65, LOT# 0203654028| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL EXTENSION, LOT# UNKNOWN