BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPG NEURO

    MDR report key: 1081348 · Received July 24, 2008

    Report

    Report Number
    2182207-2008-04280
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 24, 2008
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARRIER PIECE OF THE EXTENSION KIT WAS RETURNED. PRELIMINARY DEVICE ANALYSIS WAS NOT AVAILABLE ON THE DATE OF THIS REPORT. A F/U REPORT WILL BE SUBMITTED WHEN DEVICE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED, DURING IMPLANT OF THE NEUROSTIMULATION DEVICE, THE EXTENSION BROKE APART WHEN PULLING IT THROUGH FROM THE POCKET. ON THE SECOND ATTEMPT TO PULL THE EXTENSION THROUGH, THE LEAD WAS PULLED OUT. THE PT WAS NOT IMPLANTED WITH A DEVICE. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPG NEURO LGW MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| EXTENSION MODEL 7489 SERIAL# NHU087123V| IMPLANTED| LEAD MODEL: UNK LOT# UNK| IMPLANTED| EXPLANTED