BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2900373 · Received January 7, 2013

    Report

    Report Number
    3004209178-2013-00268
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Report Date
    December 18, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V798124, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V798124, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE PATIENT GOES INTO THE HEALTH CARE PROFESSIONALS (HCP) OFFICE FOR AN ADJUSTMENT THE PATIENT IS "FINE." AFTER THE PATIENT RETURNED HOME THE STIMULATION CHANGED AND THE PATIENT HAD A RETURN OF SYMPTOMS. THE PATIENT'S RIGHT LEG STARTED FLINGING UP IN THE AIR AND THEIR ARMS STARTED FLAPPING AND THE PATIENT HAD TO CALL EMERGENCY MEDICAL SERVICES. ONE MONTH PRIOR THE PATIENT HAD TO GO TO THE HOSPITAL FOR SEVERE HEADACHES. IT WAS NOTED WHEN THE PATIENT WAS ADJUSTED THEY WERE FINE FOR 2-3 HOURS THEN THE PATIENT HAD SEVERE HEADACHES AND INVOLUNTARY MOVEMENTS. IT WAS REPORTED THE PREVIOUS NIGHT STIMULATION HAD TO BE TURNED OFF. REPORTER STATED "THE HCP NEVER KNOWS WHAT TO DO AND WHEN THE PATIENT WAS HAVING ISSUES IT WAS NEVER AN EMERGENCY." IT WAS ALSO NOTED THE HCP TOLD THEM "HE COULD NOT SEE THEM UNTIL (B)(6)." IT WAS ALSO NOTED THE PATIENT WAS NOT SHOWN HOW TO USE THE PATIENT PROGRAMMER. "THEY WERE NOT AWARE THEY COULD TURN OFF THE PRODUCT DUE TO HORRIBLE HEADACHES." IT WAS NOTED THERE COULD BE SOME ELECTROMAGNETIC INTERFERENCE. IT WAS ALSO NOTED THE PATIENT WAS ON THE COMPUTER "ALL THE TIME" AND THE WI-FI COULD HAVE SOMETHING TO DO WITH IT. FOLLOW UP REPORTED THE REPRESENTATIVE HAD NO INFORMATION ON THE PATIENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE CAUSE OF THE EVENT WAS HIGH IMPEDANCES ON ELECTRODE PAIRS C-0, C-2, C-3, 0-2, AND 0-3. IMPLANTABLE NEUROSTIMULATOR WAS REPROGRAMMED IN (B)(6) 2012 TO AVOID HIGH IMPEDANCES AND THE PROGRAMMING WAS NOW ON C+ 1-. REPROGRAMMING SEEMED TO CORRECT THE ISSUE. SIGNS AND SYMPTOMS ASSOCIATED WITH THE REPORTED EVENT WERE INCREASED MOVEMENT IN THE RIGHT SIDE OF THE BODY. SYMPTOMS WERE NOT SEEN BY THE HEALTHCARE PROFESSIONAL (HCP). NO HOSPITALIZATION WAS REQUIRED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6344 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1