BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 1885252 · Received October 25, 2010

    Report

    Report Number
    3007566237-2010-08391
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 29, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION DOWN THE LEFT ARM. IT WAS STATED, THE IMPEDANCES ON THE PATIENT'S DEVICE "CHANGED WHEN THE DOCTOR RERAN THE IMPEDANCE TEST." THE POSSIBILITY OF A FLUID SHORT WAS DISCUSSED. THE PATIENT'S INFORMATION WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| LOT# UNK| EXPLANTED:| UNKNOWN CONVERSION TYPE: MODEL LEADN