BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5051448 · Received September 2, 2015

    Report

    Report Number
    3004209178-2015-17190
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Report Date
    August 11, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDCAL PRODUCTS: PRODUCT ID: 37603, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387-40, LOT# V001236, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40, LOT# J0337370V, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE PATIENT THAT REPORTED THE PATIENT'S NECK PAIN SUDDENLY RESURFACED IN (B)(6) 2015 AFTER BEING ALLEVIATED FOR 8 YEARS. IN ADDITION, THE PATIENT HAD SEVERE MEMORY ISSUES TO THE POINT WHERE SHE WOULD WALK INTO A STORE AND WOULD NOT REMEMBER WHY SHE WENT IN. SHE HAD BEEN LOSING THINGS IN HER HOUSE BECAUSE SHE COULDN'T REMEMBER WHERE SHE PUT THEM. THE MEMORY ISSUES WERE GRADUAL STARTING IN (B)(6) 2015. THE PATIENT WAS IMPLANTED FOR DYSTONIA AND MOVEMENT DISORDERS. FURTHER FOLLOW-UP IS BEING CONDUCTED TO DETERMINE WHAT STEPS WERE TAKEN TO RESOLVE THE NECK PAIN AND MEMORY LOSS AND HAD IT BEEN RESOLVED. IF FURTHER INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. **PLEASE SEE MANUFACTURER REPORT #3004209178-2015-17188 FOR INFORMATION ON THE PATIENT'S CONCOMITANT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583293 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC PUERTO RICO OPERATIONS CO. 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR