BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1231229 · Received November 13, 2008

    Report

    Report Number
    3004209178-2008-07412
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 15, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOR ADDITIONAL INCISION.

    Description of Event or Problem · 1

    WHILE PASSING THE EXTENSIONS, THE EXTENSION CARRIER BROKE OFF OF THE EXTENSION CARRIER STYLET. THE SURGEON MADE AN ADDITIONAL INCISION TO RETRIEVE AND PASS THE EXTENSIONS. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE. PLEASE SEE MFR REPORT# 3004209178200807413.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention EXPLANTED:| EXPLANTED:| LOT# NFW151878H| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| IMPLANTED:| EXPLANTED:| IMPLANTED:| TUNNELLING TOOLS: MODEL 3550-06| IMPLANTED:| EXTENSION: MODEL 7482| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482| LEAD: MODEL 3387S| EXPLANTED:| LEAD: MODEL 3387S