BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7234491 · Received February 1, 2018

    Report

    Report Number
    3004209178-2018-01840
    Event Type
    Malfunction
    Date Received
    February 1, 2018
    Date of Event
    January 26, 2018
    Report Date
    February 26, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529762
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE STATING THEY MET WITH THE PATIENT WHO IS NOW DOING FINE AND HAS NO COMPLICATIONS. NO FURTHER ACTIONS WERE TAKEN BECAUSE THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR PARKINSON¿S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT DID NOT FEEL LIKE THEY WERE GETTING THE SAME THERAPY AND HAD TINGLING IN THE HANDS/FINGERS, AND TOES. IT WAS NOTED THAT THE PATIENT HAD SLEPT ¿WEIRD¿ (ON (B)(6) 2018) AND THAT THE INS SITE HURT BELOW THE INCISION. IN ADDITION, IT WAS REPORTED THAT THE PATIENT USUALLY INTERVAL FOR RECHARGING WAS DAILY FOR ABOUT 40 MINUTES. HOWEVER, LATER THEY WOULD CONNECT WITH THE RECHARGER AND AFTER 5 MINUTES THEY WOULD SEE THAT THE BATTERY WAS FULL (BATTERY NOT DEPLETING AS FAST). IT WAS RECOMMENDED TO BYPASS THE BATTERY FULL SCREEN (IN CASE THE CHARGE SUFFICIENT SCREEN) TO SEE IF THE PATIENT WAS ABLE TO CONTINUE CHARGING. THE INS WAS CONFIRMED TO BE ON. THE LEAD CONNECTION CHECK ON THE PROGRAMMER SHOWED THE FOLLOWING: LCC SCROLL RIGHT INFO SCREEN (B)(4) SCROLL RIGHT NFI SCROLL RIGHT TNI O/5E 0/61 93/26 7/2 SCROLL RIGHT 1/5B SCROLL DOWN LCC 8 OK. IT WAS REPORTED THAT THE PATIENT ¿FELT THAT¿ AND THE INFORMATION CONFIRMED LEAD WAS CONNECTED. IT WAS CONFIRMED THAT THE PATIENT HAD NO FALLS, TRAUMA, MEDICAL TESTS, OR PROGRAMMING CHANGES. THE PATIENT AND MANUFACTURER¿S REPRESENTATIVE WERE REFERRED BACK TO THE HEALTHCARE PROFESSIONAL (HCP) TO CHECK IMPEDANCES/SYSTEM INTEGRITY WITH THE CLINICIAN PROGRAMMER. THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2018. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77207 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00643169529762

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR