BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3970904 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-13757
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 9, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3389S-40, LOT# V320478, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 3550-05, LOT# N255983, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION; PRODUCT ID 3389S-40, LOT# V616993, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION; PRODUCT ID 3389S-40, LOT# V320478, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SHOCKING OR JOLTING SENSATION THAT HAD STARTED 9 MONTHS PRIOR TO THE DATE OF THIS REPORT. IT WAS NOTED THAT THE PATIENT HAD 2 IMPLANTABLE NEUROSTIMULATORS (INSS). THE INS ON THE LEFT SIDE WHICH WAS FOR HIS RIGHT HAND HAD SEEMED TO BE GOING ON AND OFF AND THE PATIENT FELT A SHOCKING SENSATION IN THE RIGHT HAND. IT HAPPENED WITH THE PATIENT SAT AND RESTED HIS HEAD BACK, TURNED HIS HEAD OR WHEN HE WASHED HIS HAIR. IT WAS FURTHER NOTED THAT THE PATIENT NOTICED IT ESPECIALLY IF HE WAS ON PROGRAM A AND UP TO 4.2V. IN THE LAST COUPLE OF MONTHS PRIOR TO THE DATE OF THIS REPORT THE PATIENT COULD FEEL AN IMPULSE UP AND DOWN HIS ARM LIKE IT WAS GOING ON AND OFF WHEN WASHING HIS HAIR, SITTING DOWN ON THE FLOOR OR ROLLING HIS HEAD FROM SIDE TO SIDE. THE LEADS WERE CHECKED AND EVERYTHING WAS FINE, LEADS WERE NOT BROKEN. IT WAS NOTED THAT REPLACING THE BATTERY IN (B)(6) 2014 HAD MADE IT WORSE BECAUSE THE NEW INS HAD DIFFERENT LEVELS TO ADJUST AND THE PATIENT HAD REALLY NOTICED THE PROBLEM WHEN HE INCREASED STIMULATION. IT WAS FURTHER NOTED THAT WITH THE DEVICE OFF THE PATIENT DID NOT EXPERIENCE PULSATION/SHOCKING SENSATION. THE PATIENT¿S NEXT APPOINTMENT WAS ON (B)(6) 2014. IT WAS FURTHER NOTED THAT THE SYMPTOM OF FEELING SHOCKING HAD GRADUALLY BECOME WORSE. IT WAS NOTED THAT THE PATIENT HAD A POTENTIALLY BROKEN WIRE. THE PATIENT HAD BEEN IN A CAR ACCIDENT IN (B)(6) 2014 WHICH HAD RESULTED IN A CONCUSSION. IT WAS NOTED THAT AFTER THE ACCIDENT WHEN THE PATIENT WOULD USE GROUP A WHICH WAS A HIGHER SETTING THE PATIENT WOULD FEEL SHOCKS AT THE CONNECTOR SITE AND DOWN THE BACK OF HIS HEAD. IN (B)(6) 2014 ALL COMBINATIONS WITH 0 WERE GREATER THAN 10,000 OHMS RANGE. ON (B)(6) 2014 IMPEDANCES WERE 0/C 11804 OHMS, 0/1 22773 OHMS, 0/2 26223 OHMS, AND 0/3 26902 OHMS. THE PROGRAMMING WAS GOING TO BE CHANGED TO WORK AROUND CONTACT 0. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT. REFERENCE MANUFACTURER¿S REPORT NUMBER: 3004209178-2014-13738 FOR INFORMATION ABOUT PATIENT¿S PREVIOUS LEFT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT STILL HAD CONCERNS REGARDING THEIR DEVICE OR THERAPY, BUT WERE WORKING WITH THEIR HEALTHCARE PROVIDER OR MANUFACTURER REPRESENTATIVE. AN APPOINTMENT DATE OF (B)(6) 2014 WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447750 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR