BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2986155 · Received March 1, 2013

    Report

    Report Number
    3004209178-2013-03222
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Report Date
    February 7, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 64002 LOT# (B)(4), PRODUCT TYPE ADAPTER PRODUCT ID: 3387S-40 LOT# V241399, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3387S-40 LOT# V241399, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPEDANCES DID NOT RESOLVE POST OPERATIVELY. IT CAUSE OF THE ISSUE WAS NOT DETERMINED; THE PATIENT¿S OUTCOME WAS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH IMPEDANCES. IT WAS FURTHER REPORTED THAT MEASUREMENTS REVEALED "GREATER THAN 4000 OHMS ON UNIPOLAR PAIRS." IMPEDANCE VALUES WERE RECORDED AS FOLLOWS: "C4 = 5330 OHMS, C5 = 4557 OHMS, C6 = 4413 OHMS, AND C7 = 5101 OHMS." THESE VALUES WERE REPORTED TO HAVE BEEN THE "SAME INTRA-OPERATIVELY AND POST-OPERATIVELY, ALSO AFTER BEING RECONNECTED A FEW TIMES." IT WAS ADDITIONALLY REPORTED THAT THE BIPOLAR PAIRS WERE "MORE IN THE NORMAL RANGE" AND THEY RETURNED VALUES RANGING FROM "1889 OHMS - 3009 OHMS." IT WAS NOTED THAT THE BIPOLAR PAIR "4<(>&<)>7 WERE MORE ELEVATED WITH 3892 OHMS." IT WAS ALSO NOTED THAT THE PATIENT HAD A MEASUREMENT OF 1873 OHMS WITH THEIR PREVIOUS DEVICE. IT WAS STATED THAT "THE LEFT CHANNEL RESULTS WERE NORMAL." THE PATIENT'S THERAPEUTIC STATE WAS UNKNOWN AT THE TIME OF REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89884 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1