BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    MDR report key: 4896693 · Received July 7, 2015

    Report

    Report Number
    3007566237-2015-01897
    Event Type
    Injury
    Date Received
    July 7, 2015
    Report Date
    June 15, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 387345, LOT# V961618, SERIAL# IMPLANTED: (B)(6) 2015, PRODUCT TYPE: SCREENING DEVICE. PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD LEADS PLACED PERCUTANEOUSLY FOR A TRIAL. AFTER THE TRIAL, THE PATIENT WAS UNAVAILABLE BY PHONE AND THEY DID NOT RETURN AS SCHEDULED FOR LEAD REMOVAL. AT HOME THEY HAD CLIPPED THE LEADS OFF TO REMOVE THEM FROM THE TRIAL SCREENING CABLE AND THEY NOTED THAT THERE WAS STILL SOME WIRE AVAILABLE SO THAT THEY COULD BE REMOVED. WHEN LEAD REMOVAL WAS ATTEMPTED, THE NURSE REMOVED ONE LEAD BUT COULD NOT SEE THE WIRE OF THE SECOND. AFTER THE PHYSICIAN EXAMINED THE PATIENT, REMOVAL AT THE HOSPITAL WAS SCHEDULED. IT WAS LATER REPORTED THAT THE END OF THE LEAD COULD NOT BE LOCATED AND THE PATIENT WAS BEING SENT TO NEUROSURGERY FOR REMOVAL. THERE WERE NO SIGNS OF INFECTION, NO NEUROLOGICAL DEFICITS NOTED AND THERE WERE NO ADDITIONAL PATIENT SYMPTOMS ASSOCIATED WITH 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
    438654 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention