BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 2557162 · Received May 2, 2012

    Report

    Report Number
    3004209178-2012-02900
    Event Type
    Malfunction
    Date Received
    May 2, 2012
    Report Date
    April 4, 2012
    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
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    EXTENSION MODEL 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: NA. EXTENSION MODEL 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: NA. LEAD MODEL 3387S-40, LOT # V161576, IMPLANTED: (B)(6) 2009, EXPLANTED: NA. LEAD MODEL 3387S-40, LOT # V109650, IMPLANTED: (B)(6) 2009, EXPLANTED: NA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF EFFECT. THE PATIENT FELL AND BROKE HER HIP, HAD SURGERY AND WAS TRANSFERRED TO A REHABILITATION FACILITY. THE PATIENTS RIGHT HAND WAS SHAKING LIKE IT WAS PRIOR TO IMPLANT. THE PATIENT PLANNED TO MEET WITH A COMPANY REPRESENTATIVE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1