BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3010380 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-03904
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 7482A66 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 7482A66 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID, 37642 LOT# SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3387S-40 LOT# V411439, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3387S-40 LOT# V407602, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A TRANSIENT ISCHEMIC ATTACK (TIA). IT WAS NOTED THAT THE HEALTH CARE PROFESSIONAL STATED THE TIA WAS NOT DEVICE RELATED. IT WAS NOTED PATIENT FULLY RECOVERED THE SAME DAY THE TIA OCCURRED. PATIENT HAD HAD NUMBNESS AND TINGLING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED A LOSS OF STIMULATION AND THEN UPON TROUBLESHOOTING THE DEVICE, RECEIVED OVERSTIMULATION. THE PATIENT'S DEVICE WAS REPORTED TO BE SHUT OFF UPON INITIAL CALL FOR ASSISTANCE. WHEN THE MANUFACTURING REPRESENTATIVE ASSISTED THE PATIENT IN TURNING ON HER DEVICE, "A FEW SECONDS LATER", THE PATIENT INDICATED SHE WAS HAVING A STROKE. AN AMBULANCE WAS CALLED AND THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM. TWENTY MINUTES LATER, THE PATIENT'S HUSBAND CALLED BACK AND STATED HE "BELIEVES THE SURGE OF THE DEVICE TURNING ON, MAY HAVE SCARED HER INTO THINKING SHE WAS HAVING A STROKE, BUT IT IS BETTER TO BE SAFE AND CALL AN AMBULANCE." THERE WAS NO ADDITIONAL INFORMATION PROVIDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114424 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization