BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEUROSTIMULATOR

    MDR report key: 2638941 · Received July 3, 2012

    Report

    Report Number
    3007566237-2012-01528
    Event Type
    Injury
    Date Received
    July 3, 2012
    Report Date
    June 5, 2012
    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

    (B)(4): LEAD MODEL UNKNOWN, LOT# UNKNOWN, IMPLANTED: UNKNOWN, EXPLANTED: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT ONE TIME THE PATIENT'S LEAD FRACTURED OR "PULLED" AND HAD TO BE REVISED. ADDITIONAL INFORMATION HAS BEEN REQ UESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention