BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 1231167 · Received November 12, 2008

    Report

    Report Number
    3004209178-2008-07400
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 15, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HCP REPORTED THAT IMPEDANCES WERE LESS THAN 250 OHMS. NO PT SYMPTOMS OR DEVICE TROUBLESHOOTING WAS REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR LEAD: MODEL 3387| IMPLANTED:| LEAD: MODEL 3387| PROGRAMMER: MODEL 7436| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482| EXPLANTED:| EXTENSION: MODEL 7482| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED: