BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 921631 · Received September 21, 2007

    Report

    Report Number
    3004209178-2007-02701
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Report Date
    July 24, 2006
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION NUMBER #E2007022 WHICH COVERS A 2-YEAR RETROSPECTIVE REVIEW OF EVENTS REPORTED BY CONSUMERS BETWEEN 2005 AND 2006 (INCLUSIVE). THIS EXEMPTION WAS GRANTED TO SATISFY MEDTRONIC'S MDR OBLIGATIONS FOR ANY PREVIOUSLY UNREPORTED SERIOUS INJURY, DEATH AND MALFUNCTION EVENTS FOUND DURING THIS REVIEW. THIS MEDWATCH REPORT REPRESENTS 2 UNREPORTED MALFUNCTION EVENTS FOR MODEL 7428 FOR THE ABOVE TIME PERIOD (ALL PRODUCT FROM MHY). THIS TOTAL INCLUDES THE EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED HAVING AN MRI TO CHECK FOR CLOTS IN HIS CHEST AND SINCE THAT TIME THE STIMULATOR HAS NOT BEEN WORKING. THE MANUFACTURER REPRESENTATIVE RECOMMENDED CONTACTING THE PHYSICIAN TO EVALUATE THE DEVICE.

    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 YR Other IMPLANTED| EXTENSION MODEL 7482 LOT#NHU078967V| IMPLANTED| LEAD MODEL 3387 LOT# J0455438V| EXPLANTED| LEAD MODEL 3387 LOT# J0455438V| EXPLANTED| IMPLANTED| EXPLANTED| EXTENSION MODEL 7482 LOT# NHU078971V| EXPLANTED| IMPLANTED