BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 9012842 · Received September 12, 2019

    Report

    Report Number
    3004209178-2019-17554
    Event Type
    Malfunction
    Date Received
    September 12, 2019
    Date of Event
    September 4, 2019
    Report Date
    September 25, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169864214
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP), VIA A MANUFACTURING REPRESENTATIVE (REP), REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR PARKINSON'S DISEASE AND DBS (DEEP BRAIN STIMULATION) THERAPY INDICATIONS. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING STRONG, TRANSIENT, INTERMITTENT PARESTHESIA ON THE RIGHT SIDE OF THEIR BODY, FACE, ARM/HAND, AND LEG. IT WAS HAPPENING 3-5 TIMES A DAY WHEN DOING CERTAIN ACTIVITIES THAT POSSIBLE PUT STRAIN ON THE LEFT BRAIN DBS SYSTEM. IT WAS NOTED THE LEFT EXTENSION WAS MUCH MORE PROMINENT IN THE NECK THAN THE RIGHT SIDE. THERE WAS NO PARTICULAR MOVEMENT THAT THE PATIENT COULD DESCRIBE THAT REPRODUCED THE FEELING. AN APPOINTMENT WAS TO BE MADE WITH THEIR NEUROLOGIST AND IMPEDANCES WERE TO BE TESTED TO CHECK SYSTEM INTEGRITY. NO ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS WERE REPORTED TO HAVE LED OR CONTRIBUTED TO THE ISSUE. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THERE WAS A FOLLOW UP APPOINTMENT FOR (B)(6) 2019 AND THE PATIENT/FAMILY INITIALLY REPORTED THE EVENT. THE REP LATER SAID THE CALLER WALKED THE PATIENT THROUGH PERFORMING LCC OVER THE PHONE BUT UPON DOING SO THEY GOT THE ¿IN THE BOX¿ ICON. IT WAS REVIEWED THAT IT WAS A KNOWN ISSUE IN WHICH IF THE INS HAD BEEN INTERROGATED WITH THE TABLET LCC FUNCTION WOULD NO LONGER WORK. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP STATING THAT IMPEDANCES WERE CHECKED AND WERE AS FOLLOWS: C3 715 03 100 (SHORT) C2 2862 C1 2911 C0 715 13 2321 23 2210 02 2335 12 2739 01 2375 THE CALLER SAID THE PATIENT WAS PROGRAMMED TO C+3-. THE ISSUES WERE WITH THE LEFT SYSTEM, THE RIGHT SYSTEM WAS OK. IMPEDANCES WERE REVIEWED FOR CONTACT 0/3 AND ¿REPEAT VALUE¿ BETWEEN C0/C3. THE CALLER WOULD PURSUE FURTHER TROUBLESHOOTING TO ADDRESS SENSATION THAT WENT DOWN TO THE HIP/FOOT/LEG AS WELL AS THE PATIENT¿S FACE. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP) INDICATED THE CAUSE OF THE SHORT WAS NOT ABLE TO BE DETERMINED DEFINITIVELY AND THE ISSUE WAS ONLY ON THE LEFT BRAIN SYSTEM, NOT ON THE RIGHT BRAIN SYSTEM. BASELINE ELECTRODE IMPEDANCES WERE TAKEN ON THE LEFT SIDE, THE PATIENT PUT STRESS ON THE SYSTEM BY TURNING THEIR HEAD LEFT AND RIGHT, AND CROSSING ARMS ACROSS THEIR CHEST, ETC. THE PARATHESIAS WERE ABLE TO BE REPEATED WHEN CROSSING THE LEFT ARM ACROSS THE CHEST AND REACHING OUT. THE PATIENT FELT THE SAME FEELING AT HOME WHEN THEY WENT TO OPEN THE REFRIGERATOR. IT WAS REPORTED THE TINGLING HAD BEEN RESOLVED AS THEY HAD BEEN REPROGRAMMED TO THE BIPOLAR PAIR OF 2+, 3- AT A SLIGHTLY HIGHER VOLTAGE THAN THE MONOPOLAR C+, 3- THEY CAME IN ON. THE PATIENT REPEATED SEVERAL MOVEMENTS AS DESCRIBED ABOVE AND NO PARESTHESIAS COULD BE PRODUCED. THEIR PARKINSON'S DISEASE SYMPTOMS WERE EQUALLY CONTROLLED. THE INFORMATION HAD BEEN CONFIRMED WITH THE PHYSICIAN/ACCOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807487 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603 00643169864214

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR