BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 1950085 · Received December 7, 2010

    Report

    Report Number
    3004209178-2010-10268
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 26, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BIPOLAR IMPEDANCE READINGS WERE GREATER THAN 4000 OHMS ON ALL LEFT-SIDE ELECTRODE COMBINATIONS. IMPEDANCES WERE NORMAL 6 WEEKS EARLIER. NO TRAUMA OR FALLS WERE ASSOCIATED WITH THE EVENT. THERAPY HADN'T BEEN TITRATED TO FULL BENEFIT, SO IT WAS DIFFICULT TO DISCERN IF THE PT EXPERIENCED LACK OF SYMPTOM CONTROL ASSOCIATED WITH THE HIGH IMPEDANCES. ADD'L INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1