BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR EXTENSION PASSER ACCESSORY KIT

    MDR report key: 4899631 · Received July 8, 2015

    Report

    Report Number
    3007566237-2015-01907
    Event Type
    Injury
    Date Received
    July 8, 2015
    Date of Event
    March 18, 2015
    Report Date
    June 15, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A MALFUNCTION. THE CONE LIKE PLASTIC TIP OF THE PLASTIC SHEATH FOR THE TUNNELER BROKE OFF INSIDE THE PATIENT¿S NECK DURING TUNNELING. THE TIP WAS UNABLE TO BE LOCATED BY O-ARM, ULTRASOUND, OR MANUAL EXPLORATION BY SURGEON. THE TIP WAS NOT DETECTABLE BY X-RAY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442388 IMPLANTABLE NEUROSTIMULATOR EXTENSION PASSER ACCESSORY KIT STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 365538 N519648

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention