BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    MDR report key: 3733925 · Received April 8, 2014

    Report

    Report Number
    3007566237-2014-00959
    Event Type
    Injury
    Date Received
    April 8, 2014
    Report Date
    March 19, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3877-60, LOT# 0206410913, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3877-60, LOT# 0206410914, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD, (B)(4), FOUND THAT THE #0 CONDUCTOR WAS BROKEN 0.5 CENTIMETERS FROM THE DISTAL END. ANALYSIS OF THE LEAD, 0206410914, FOUND THAT THE #2 CONDUCTOR WAS BROKEN 3 CENTIMETERS FROM THE PROXIMAL END, WITHIN 10 CENTIMETERS OF THE CONNECTOR AREA.

    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 THE LEADS MIGRATED. IT WAS NOTED THAT ONE OF THE LEADS WAS BROKEN AT THE TIP OF THE LEAD AT CONTACT 0. IT WAS NOTED THAT THE LEADS WERE REPLACED AND WOULD BE RETURNED. IT WAS NOTED THAT IMPEDANCE TESTING, X-RAYS, AND REPROGRAMMING WAS PERFORMED. IT WAS NOTED THAT THE TWO LEADS WERE PLACED FOR SUBCUTANEOUS FOR LOWER BACK PAIN. IT WAS NOTED THAT THE PATIENT HAD VERY GOOD RESULTS ALMOST A YEAR UNTIL THE PATIENT FELL ON THEIR BUTT AND THE LEADS DISPLACED IN THE BACK. AFTER THAT TIME THE PATIENT HAD VERY BAD EFFECT OF THE STIMULATION. IT WAS NOTED THAT THE HEALTH CARE PROFESSIONAL (HCP) TRIED TO REPROGRAM WITH NO LUCK. IT WAS NOTED THAT ON THE LEFT SIDE THE PATIENT HAD REALLY BAD STIMULATION, ¿LIKE VERY STICKY STIMULATION.¿ IT WAS NOTED THAT THE PATIENT HAD PAIN AT THE LEAD LOCATION. IT WAS NOTED THAT BECAUSE OF THE LEAD MIGRATION THE PATIENT COULD NOT HAVE ANY EFFECT OF THE THERAPY. IT WAS NOTED THAT IN THE OPERATING ROOM IT WAS FOUND OUT UNDER EXPLANATION THAT THE LEFT LEAD WAS BROKEN BETWEEN CONTACT 0 AND 1. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE COULD NOT SEE ANYTHING ON THE RIGHT LEAD. IT WAS NOTED THAT AFTER REPLACEMENT OF THE LEADS, THE PATIENT FELT GOOD EFFECT AGAIN OF THE STIMULATION AND THE PATIENT WAS VERY HAPPY. IT WAS NOTED THAT THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211539 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Required Intervention