BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2831266 · Received November 14, 2012

    Report

    Report Number
    3007566237-2012-02704
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 15, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3550-39, SERIAL# UNKNOWN, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S CERVICAL LEAD HAD MIGRATED FROM THE CERVICAL LEVEL TO THE FRONTAL LOBE OF HER BRAIN BECAUSE HER LEAD WAS NOT SECURED ADEQUATELY. IT WAS THOUGHT THE ANCHOR USED WAS NOT FIXED PROPERLY OR THERE WAS A FAILURE OF THE ANCHOR. SURGICAL INTERVENTION WAS REQUIRED; AN UNKNOWN DEVICE WAS EXPLANTED. NO PATIENT SYMPTOMS OR INJURIES WERE REPORTED RELATED TO THE EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE ANCHOR WAS INTACT. THE LEAD HAD SLIPPED THROUGH THE ANCHOR WHICH HAD NOT BEEN SECURED CORRECTLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention