BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 2784222 · Received October 11, 2012

    Report

    Report Number
    3004209178-2012-09111
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Report Date
    September 11, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: PRODUCT TYPE EXTENSION; PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 7438, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID (B)(4), LOT # V000654, IMPLANTED: (B)(4) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3387-40, LOT # V001440, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OUT-OF-RANGE IMPEDANCE VALUES WERE MEASURED. THIS ISSUE WAS NOTED ON THE LEFT IMPLANTABLE NEUROSTIMULATOR (INS), SPECIFICALLY ON THE 0 THROUGH 3 CONTACTS. IT WAS INDICATED THAT "THIS PORT WAS NOT BEING USED" AND THAT THE "4 AND 7 COMBINATION" CONTACT WAS THE "ONE DELIVERING THERAPY." NORMAL IMPEDANCE MEASUREMENTS WERE MEASURED ON THE CONTACTS 4 THROUGH 7. IT WAS FURTHER NOTED THAT THE PATIENT EXPERIENCED A DECREASE IN THERAPY ABOUT A MONTH AGO. THE PATIENT HAD BOTH INS DEVICES EXPLANTED DUE TO NORMAL BATTERY DEPLETION. IT WAS NOTED THAT THE INS DEVICES WERE AT 2.36V AND 2.6V BEFORE THEY WERE REPLACED. IT WAS FURTHER REPORTED THAT THE CONTACTS 4 THROUGH 7 REVEALED NORMAL IMPEDANCE MEASUREMENTS BECAUSE THE PATIENT'S SYSTEM "HAD BEEN SET UP USING 4 THROUGH 7 AND NOT 0 THROUGH 3." NO INTERVENTION WAS REQUIRED DUE TO THIS EVENT. IT WAS NOTED THAT THE OUT-OF-RANGE IMPEDANCES WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1