BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6095536 · Received November 11, 2016

    Report

    Report Number
    3004209178-2016-23738
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    October 22, 2016
    Report Date
    December 19, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994761057
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2015, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE PATIENT WAS SEEN ON (B)(6) AND THEIR TREMOR CONTROL WAS BACK TO NORMAL. IMPEDANCES WERE GOOD EXCEPT FOR A SHORT ON 0/2 ON THE LEFT SIDE, AND THERAPY IMPEDANCE WAS NORMAL. IT IS UNKNOWN IF THE SHORT WAS EXISTING OR NEW, AND THE PATIENT IS DOING WELL. ON (B)(6) THE PATIENT REPORTED THAT THEY DON'T KNOW WHAT LED TO THE HEAD INJURY, AND THAT IT WAS THE RESULT OF A NIGHTMARE. IT WAS STATED THAT THEIR TREMOR WENT AWAY ABOUT 8-10 DAYS FOLLOWING THE INJURY, AND THE HEAD INJURY AND RIGHT SIDE TREMORS HAVE BEEN RESOLVED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR PARKINSONS DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT SUFFERED A HEAD INJURY THE PAST WEEKEND BEFORE THE REPORT. THE PATIENT ADDED THAT FOLLOWING HIS HEAD INJURY THEY HAD EXPERIENCED A RETURN IN TREMOR SYMPTOMS ON THEIR RIGHT SIDE. PATIENT STATED THAT THEY NEEDED TO ADJUST THEIR STIMULATION AND CONTACTED THEIR DOCTOR WHO REDIRECTED THEM TO A COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT. IT WAS REPORTED THAT THE HEAD INJURY WAS UNRELATED TO THE DEVICE; THE PATIENT FELL OUT OF BED. IT WAS ALSO STATED THAT THE PATIENT WENT TO THE EMERGENCY ROOM (ER) BECAUSE OF THE HEAD INJURY. THE PATIENT ALSO CONFIRMED THAT THE TREMORS AND HEAD INJURY WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747414 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602 00613994761057

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR