BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD

    MDR report key: 5233821 · Received November 18, 2015

    Report

    Report Number
    3007566237-2015-03367
    Event Type
    Injury
    Date Received
    November 18, 2015
    Report Date
    November 10, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU _INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_EXT, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED VIA THE COMPANY REPRESENTATIVE (REP) THAT HE WAS FEELING THE WIRES PULLING. THE PATIENT WAS REFERRED TO FOLLOW UP WITH HIS PHYSICIAN. THE REP CLARIFIED THAT THE DEVICE WAS IMPLANTED FOR OCCIPITAL NERVE STIMULATION (ONS). THE DEVICE SHOULD BE REVISED ON (B)(6)2015. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE COMPANY REPRESENTATIVE (REP) REPORTED A MONTH LATER THAT THE CAUSE WAS THE PATIENT HAD A HORSE ACCIDENT AND IT WAS SINCE THEN THAT HE STARTED TO FEEL HIS WIRES PULLING, BUT THE CAUSE WAS NOT THAT CLEAR. DIAGNOSTICS PERFORMED WAS THE PATIENT WAS PRESCRIBED A CERVICO-THORACIC CORSET THAT HELPED HIM. SURGERY WAS DONE LAST WEEK. THE SURGEON FOUND THE LOOPS UNDER THE BATTERY AND BEHIND THE EAR, THE LOOPS WERE LARGE ENOUGH TO GIVE HIM THE SLACK BUT WERE ALL TIGHTLY TAKEN INTO THE TISSUES (THEY COULD NOT SLIDE). THE SURGEON DISSECTED THE TISSUES AND REPLACED THE LEAD WITH TWO LOOPS. IT WAS TOO SOON TO SAY IF THE FEELING THE WIRES PULLING HAD RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764669 LEAD STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_UNKNOWN_LEAD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention