BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2781393 · Received October 10, 2012

    Report

    Report Number
    3004209178-2012-09086
    Event Type
    Injury
    Date Received
    October 10, 2012
    Report Date
    September 12, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 748240 SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 748240 SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3389S-40 LOT# V011992, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3389S-40 LOT# V011992, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POSSIBLE LEAD FRACTURE OR BREAKAGE. THE PATIENT'S RIGHT HEMISPHERE WAS LESS EFFECTIVE AND PATIENT HAD SMALL AMOUNT OF TREMOR. THE LEFT SIDE WAS WORKING FINE. THE IMPEDANCE TEST ON RIGHT HEMISPHERE SHOWED GREATER THAN 4000 OHMS. ELECTRODE IMPEDANCES WITH LESS THAN 15 MA SHOWED WITHIN RANGE VALUES. THERE WERE NO MALFUNCTIONS SEEN BUT PATIENT HAD DECREASING THERAPY IN LEFT HAND AND PATIENT HAD LEFT LEG TREMORS. THE PATIENT WAS SCHEDULED FOR X-RAY TEST TO LOOK FOR A VISIBLE LEAD BREAK OR FRACTURE. SUBSEQUENT REVISION WAS EXPECTED, BUT NOTHING WAS SCHEDULED AT THIS TIME. FOLLOW-UP INFORMATION REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. THERE WERE HIGH IMPEDANCES AT CONTACT 0 OF THE RIGHT HEMISPHERE CRANIAL ELECTRODE. THE ISSUE WAS DUE TO LEAD OR EXTENSION BREAKAGE. X-RAYS WERE PERFORMED ON (B)(6) 2012 AND IT SHOWED NO OBVIOUS ABNORMALITY. IT WAS NOTED THAT THERE WAS "EXPLORATION OF THE DEEP BRAIN STIMULATOR" AND REVISION WILL BE SCHEDULED. PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THE EVENT. THE PATIENT OUTCOME WAS NOTED AS NON-SERIOUS INJURY.

    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 Required Intervention