BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3852943 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-10233
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Report Date
    June 3, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387-40, LOT# J0214131V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 3387-40, LOT# J0235433V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387-40, LOT# J0214131V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 3387-40, LOT# J0235433V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A NEW IMPLANTABLE NEUROSTIMULATOR (INS) ON (B)(6) 2014. IT WAS NOTED THAT THE PATIENT HAD WOKEN UP FROM THE SURGERY MORE ALERT THAN SHE HAD BEEN IN THE PAST 6 MONTHS PRIOR TO THE DATE OF THIS REPORT. THE PATIENT HAD CONTINUED TO FEEL THAT WAY UNTIL (B)(6) 2014. ON (B)(6) 2014 THE PATIENT HAD GONE THE OTHER DIRECTION AND WENT BACK TO SLEEPING MORE LIKE SHE WAS BEFORE THE DEVICE WAS IMPLANTED. IT WAS LATER REPORTED THAT THE PATIENT¿S INSS WERE REPLACED ON (B)(6) 2014. PATIENT¿S SYMPTOMS WERE HELPED ON (B)(6) 2014. IT WAS NOTED THE PATIENT WAS ¿SUPER GOOD/COULD TALK, WALK IT WAS AMAZING FOR THE WHOLE DAY ON FRIDAY; THEN SHE GOT UP SATURDAY MORNING AND THE SYMPTOMS WENT RIGHT BACK.¿ IT WAS NOTED THAT THE SYMPTOMS HAD REMAINED THE SAME SINCE SATURDAY. THERE WAS A LOSS OF THERAPEUTIC EFFECT. PATIENT WAS NOT ADEQUATELY TRAINED ON USING THE DEVICE. IT WAS NOTED THAT THE PROGRAMMER WAS NOT LIKE THE OLD ONE. IT WAS FURTHER NOTED THAT NO ONE HAD SHOWN HIM HOW TO OPERATE IT. THE RIGHT INS SHOWED ON AND OK BUT THE INS ON THE LEFT SHOWED POOR COMMUNICATION. THE LEFT SIDE WAS CHECKED SEVERAL TIMES. PATIENT HAD AN APPOINTMENT ON (B)(6) 2014. PATIENT HAD A RETURN OF SYMPTOMS. IT WAS NOTED THAT THE PATIENT¿S FRIEND OR FAMILY MEMBER WAS CONCERNED ABOUT SEEING THE POOR COMMUNICATION ON THE SCREEN ON THE ONE SIDE. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD AN APPOINTMENT WITH THE HEALTHCARE PROFESSIONAL (HCP) ON (B)(6) 2014. IT WAS NOTED THAT THERE WAS PROBLEMS GETTING THE PATIENT¿S IMPLANT PROGRAMMED RIGHT. PATIENT NEEDED HELP WITH THE IMPLANT. IT WAS REPORTED THAT ONE OF THE WIRES WAS NOT WORKING ABOUT 1 MONTH PRIOR TO (B)(6) 2014. IT WAS NOTED THAT THE HEALTHCARE PROFESSIONAL THOUGHT IT WAS DUE TO THE AGE OF THE LEAD WIRE. IT WAS UNKNOWN HOW LONG THE LEAD WIRE HAD NOT BEEN WORKING. THE PATIENT HAD AN APPOINTMENT THE WEEK FOLLOWING THE DATE OF THIS REPORT WITH THEIR HEALTHCARE PROFESSIONAL. PATIENT WAS NOT A CANDIDATE FOR MORE SURGERY. IT WAS PREVIOUSLY NOT PROGRAMMED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331315 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR