BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3983832 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-14017
    Event Type
    Injury
    Date Received
    August 6, 2014
    Report Date
    July 15, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7436, SERIAL# (B)(4), IMPLANTED: 2004 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3387-40, LOT# J0443941V, IMPLANTED: 2004 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: 2004 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3387-40, LOT# J0443941V, IMPLANTED: 2004 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: 2004 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3387-40, LOT# J0443941V, IMPLANTED: 2004 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3387-40, LOT# J0443941V, IMPLANTED: 2004 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: 2004 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: 2004 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ABOUT 4 WEEKS AFTER THE IMPLANT DATE, THE WIRES THAT WENT INTO THE PATIENT¿S HEAD BECAME INFECTED. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THEY ALSO TRIED TO CLEAN OUT THE INFECTION. THE PATIENT HAD THE IMPLANT FOR 5-6 YEARS BEFORE IT HAD TO BE REMOVED BECAUSE, THEY COULD NOT GET RID OF THE INFECTION. THE PATIENT DID NOT WANT TO HAVE THE DEVICE REMOVED BECAUSE, IT HELPED THEM SO MUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461092 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention