BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 X 8 SYNERGY EXTENSION KIT

    MDR report key: 2081497 · Received April 20, 2011

    Report

    Report Number
    3007566237-2011-02958
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, DURING AN IMPLANT PROCEDURE, THE CARRIER BROKE WHILE TUNNELING FOR THE LEAD AND EXTENSION. A SPARE TUNNELING TOOL WAS AVAILABLE AND USED TO COMPLETE THE IMPLANT PROCEDURE. THE STIMULATOR WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1 X 8 SYNERGY EXTENSION KIT LGW MEDTRONIC NEUROMODULATION 7472 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 STIM ACCESSORY: MODEL 3550-06, LOT # UNK| EXPLANTED:| IMPLANTED: