BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 4860147 · Received June 22, 2015

    Report

    Report Number
    3004209178-2015-12001
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Report Date
    June 3, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2015 THE PATIENT¿S SYMPTOMS OF LIMB RIGIDITY GOT WORSE. IN (B)(6) 2015, THE PATIENT WAS REPROGRAMMED IN THE HOSPITAL AND IMPEDANCES OF GREATER THAN 4,000 OHMS WERE MEASURED. THE CAUSE OF THE HIGH IMPEDANCES WAS UNKNOWN. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403924 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR