BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 1213778 · Received October 22, 2008

    Report

    Report Number
    3004209178-2008-06740
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 24, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT HAD BEEN FINE SINCE IMPLANT, UNTIL THE LAST MONTH OR TWO. SINCE THEN, THE PT'S BLOOD PRESSURE HAD BEEN UP AND DOWN AND HE WAS PASSING OUT. HE PASSED OUT FOUR TIMES. THREE OF THE TIMES, HIS BLOOD PRESSURE WAS VERY LOW (99/67); IN 2008, WHEN HE PASSED OUT, HIS BLOOD PRESSURE WAS HIGH (167/113). THE PT'S WIFE WAS WONDERING IF THE DEEP BRAIN STIMULATION SYSTEM COULD BE CAUSING THE PROBLEM. SHE STATED HIS DOCTOR DIDN'T HAVE AN ANSWER. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADD'L 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 57 YR LEAD: MODEL 3387| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3387| EXPLANTED:| PROGRAMMER: MODEL 7436| EXTENSION: MODEL 7482