BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 2832211 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-10266
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    October 16, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 7436, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387-40, LOT# V001355, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3387-40, LOT# J0546586V, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 'THE DEVICE WAS DEFECTIVE' AND HAD NOT WORKED FOR 'SOME TIME.' IT WAS FURTHER REPORTED THAT THE PATIENT HAD A FALL ABOUT TWO YEARS PRIOR TO THE REPORT WHERE SHE HIT HER HEAD AND SUFFERED A CONCUSSION. IT WAS NOTED THAT THE PATIENT HAD A MRI AND IT WAS SEEN THAT THE 'WIRES WERE IN THE WRONG LOCATION.' IT WAS FURTHER NOTED THAT THE MRI WAS TAKEN 'A COUPLE OF YEARS AGO.' IT WAS ALSO REPORTED THAT THE PATIENT NOTICED THAT THE DEVICE HAD DROPPED LOWER INTO HER BREAST AREA AND THAT THE LEAD HAD STRETCHED. IT WAS ALSO REPORTED THAT THE PATIENT WAS EXPERIENCING A BURNING SENSATION AND 'HEAT FLASH' ON HER NECK. THE PATIENT WAS ALSO EXPERIENCING A BURNING AT THE LEAD AND DEVICE LOCATION WHICH STARTED 'A COUPLE MONTHS' PRIOR TO THE REPORT AND SHE IS UNABLE TO TOUCH THE AREA. THE PATIENT STATED THAT SHE WAS AFRAID TO TURN THE THERAPY ON. THE DEVICE WAS REPORTEDLY SET AT 1 VOLT WHERE AS IT USED TO BE SET AT 4.5 VOLTS. THE DEVICE WAS REPORTEDLY TURNED DOWN BY A MANUFACTURE REPRESENTATIVE. THE PATIENT ALSO STATED THAT 'HER FALL HAS NOT CAUSED ALL THE PROBLEMS AND THE DEVICE IS DEFECTIVE.' IT WAS FURTHER REPORTED THAT THERE WAS A LOSS OF EFFICACY WHICH WAS UNRELATED TO STIMULATION THERAPY. THE PATIENT WAS USING A BONE GROWTH STIMULATOR CALLED 'ORTHO FIX' TO HELP HEAL HER NECK AND BACK. SHE REPORTEDLY WAS SUPPOSED TO USE THE BONE GROWTH STIMULATOR FOR 8 MONTHS BUT ONLY USED IT FOR 2 MONTHS BECAUSE OF THE ISSUES IT CAUSED. IT WAS ALSO REPORTED THAT THE PATIENT CAN ONLY LIE ON HER RIGHT SIDE, NOT HER LEFT, BECAUSE HER IMPLANTED DEVICE 'FLOPS AROUND.' THE PATIENT REPORTEDLY COULD 'PUT HER WHOLE HAND AROUND THE DEVICE.' IT WAS ALSO REPORTED THAT THE PATIENT IS HAVING TREMORS AGAIN AND A BURNING ON THE BACK. IT WAS ALSO REPORTED THE LEADS HAVE MOVED. THE NEXT DAY IT WAS REPORTED THAT THE IMPLANTING PHYSICIAN MADE 'NUMEROUS MISTAKES' AND THAT 'IT NEEDED TO BE REDONE.' IT WAS ALSO NOTED THAT THE IMPLANTING PHYSICIAN 'DID NOT FOLLOW THE PLAN FOR THE WIRE SET UP.' THE PATIENT REPORTEDLY HAD NOT USED HER THERAPY FOR OVER 9 MONTHS.

    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