BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 1865101 · Received October 6, 2010

    Report

    Report Number
    9614453-2010-07651
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD 3 TO 4 ACTIVATIONS, EVEN THOUGH THE PT HAD NO ACCESS TO A PT PROGRAMMER OR PHYSICIAN PROGRAMMER. DURING 3 DAYS OF HOSPITALIZATION, ANOTHER 3 ACTIVATIONS WERE DOCUMENTED. THE PT OUTCOME WAS REPORTED AS OK. THREE DAYS LATER, IT WAS REPORTED THAT THE DEVICE WAS PERFORMING WELL, NO MORE ACTIVATIONS WERE DOCUMENTED. THE PT HAD NO PROGRAMMER. PT LOST TRUST IN THE DEVICE. REPLACEMENT WAS SCHEDULED. THE DEVICE WILL BE RETURNED FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC EUROPE SARL 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1