BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2860693 · Received December 6, 2012

    Report

    Report Number
    3004209178-2012-11255
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 12, 2012
    Report Date
    July 30, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 7482-51 LOT# SERIAL# (B)(4), PRODUCT TYPE EXTENSION PRODUCT ID, 7482-51 LOT# SERIAL# (B)(4), PRODUCT TYPE EXTENSION PRODUCT ID, 3389S-40 LOT# V533559, PRODUCT TYPE LEAD PRODUCT ID, 3389S-40 LOT# V562006, PRODUCT TYPE LEAD (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL UNDER "INFECTION CONTROL THERAPY", AND WAITING FOR THE EXPLANT O PERATION. IF MORE INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A HIGH FEVER (38-40°C) SHORTLY AFTER IMPLANT. IT WAS REPORTED THAT THE LOCAL HOSPITAL SUSPECTED A PULMONARY INFECTION. A TRACHEAL RESECTION WAS PERFORMED AND A LARGE AMOUNT OF ANTIBIOTICS WERE USED WITHOUT RESOLUTION. IT WAS STATED THAT THE IMPLANT WOUNDS DID NOT SHOW SIGNS OF INFECTION. IT WAS NOTED THAT THE PATIENT STILL HAD A FEVER AND WAS IN A LIGHT COMA. THE HEALTHCARE PROFESSIONAL (HCP) AND THE PATIENT'S FAMILY CONSIDERED EXPLANTING DEVICE; HOWEVER, THE DEVICE REMAINS IN PATIENT AT THE DATE OF THIS REPORT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS UNAVAILABLE AT THE DATE OF THIS REPORT. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    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 Hospitalization| L| R