BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUNNELING TOOL ACCESSORY

    MDR report key: 1052996 · Received May 27, 2008

    Report

    Report Number
    2182207-2008-02818
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 24, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MDM
    PMA / PMN Number
    CLASS EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CARRIER OF THE TUNNELING TOOL BROKE AT THE CONNECTION BETWEEN THE TWO SLOTS DESIGNED FOR ATTACHING THE LEAD CONNECTION BLOCKS OF THE EXTENSIONS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUNNELING TOOL ACCESSORY MDM MEDTRONIC NEUROMODULATION 3655 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 EXTENSION MODEL 37082| EXPLANTED: