BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3770141 · Received April 24, 2014

    Report

    Report Number
    3004209178-2014-08047
    Event Type
    Injury
    Date Received
    April 24, 2014
    Report Date
    April 4, 2014
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3389S-40, LOT# V078937, IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3389S-40, LOT# V078937, IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD AN IMPLANTABLE NEUROSTIMULATOR (INS) EXPLANTED BECAUSE, THEY WERE TOLD IT WAS FAULTY AND THE BATTERY MIGHT FAIL. IT WAS NOTED, IT DID NOT FAIL ON THE PATIENT ¿BUT THE CONCERN WAS THAT IT WOULD.¿ IT WAS STATED, THEIR BATTERY DID NOT GO OUT BUT THEY HAD TO ¿KEEP TRACK OF THE AMOUNT OF VOLTAGE IN THERE BECAUSE ONCE IT DROPPED BELOW A CERTAIN NUMBER THERE WAS A REAL CONCERN.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249394 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention