BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 9146152 · Received October 2, 2019

    Report

    Report Number
    3004209178-2019-18836
    Event Type
    Malfunction
    Date Received
    October 2, 2019
    Date of Event
    August 16, 2019
    Report Date
    October 2, 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
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT#:VA0LF52, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT#: V875361, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3387S-40, SERIAL/LOT #: (B)(4), UBD: 14-MAY-2017, UDI#: (B)(4); PRODUCT ID: 3387S-40, SERIAL/LOT #: (B)(4), UBD: 26-AUG-2014, UDI#: (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 CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR ESSENTIAL TREMOR AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT WAS ASKING FOR PREVIOUS IMPLANT DATES. THEY STATE THE INS WAS REPLACED THIS PAST FRIDAY ON (B)(6) 2019. THEY SAID THEY DON'T KNOW IF IT WAS REPLACED DUE TO A PROBLEM, BUT IT HAS DONE ABSOLUTELY NOTHING, THE TREMOR IS STILL THE SAME AND IT'S REALLY BAD SO THEY WENT THROUGH ALL OF THIS FOR NOTHING." NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT REPORTING THAT THE LEFT SIDE IMPLANT IS NOT WORKING RIGHT SINCE IMPLANT. THEY STATE THE LEADS ARE "NOT REGISTERING" AND HER RIGHT HAND IS SHAKING SO BAD SHE CAN'T EAT OR WRITE. PATIENT STATED THEY ARE WORKING WITH HER DOCTOR ON THIS. THE STATED THE RIGHT INS WAS REPLACED ON (B)(6) 2019 AND IT IS WORKING GREAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938313 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603 00643169864214

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR