BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 1181217 · Received September 30, 2008

    Report

    Report Number
    2182207-2008-06233
    Event Type
    Injury
    Date Received
    September 30, 2008
    Report Date
    September 5, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL (HCP) STATED THAT HE HAD A CARRIER SNAP AND BECOME LODGED IN A PATIENT'S NECK. THE HCP DID NOT KNOW THE PATIENT'S NAME OR SURGERY DATE AND DID NOT PROVIDE ANY ADDITIONAL DETAILS REGARDING THE EVENT. IT WAS BELIEVED THAT IT HAD HAPPENED SOME TIME AGO. FURTHER FOLLOW-UP IS NOT POSSIBLE DUE TO THE LACK OF PATIENT AND DEVICE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN IMPLANTABLE NEUROSTIMULATOR MHY MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TUNNELING TOOL MODEL UNKNOWN LOT # UNKNOWN| EXTENSTION MODEL UNKNOWN LOT# UNKNOWN| LEAD MODEL UNKNOWN LOT # UNKNOWN