BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 1181782 · Received September 30, 2008

    Report

    Report Number
    3004209178-2008-06232
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 5, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO IMPLANT THE EXTENSIONS, THE EXTENSION CARRIER (THAT COMES WITH THE TUNNELER) BROKE IN THE PT'S NECK AND DID NOT COMPLETELY PASS THROUGH THE TUNNELED SKIN TO THE UPPER INCISION. THE SURGEON HAD A VERY DIFFICULTY TIME DISLODGING THE CARRIER AND EXTENSIONS FROM THE PT. THE EXTENSIONS ENDED UP DAMAGED. A NEW SET OF EXTENSIONS WERE USED AND SUCCESSFULLY PASSED. THE PT WAS NOT INJURED OR HARMED. THE SURGERY WAS COMPLETED WITHOUT ANY FURTHER ISSUES. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR EXTENSION: MODEL 7482| STIM ACCESSORY: MODEL TUNNELING TOOL/CARRIER| PROGRAMMER: MODEL 7436| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482| EXPLANTED:| LEAD: MODEL 3887| IMPLANTED:| LOT UNK| IMPLANTED:| IMPLANTED:| EXPLANTED: