BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 13404620 · Received January 31, 2022

    Report

    Report Number
    3004209178-2022-01431
    Event Type
    Injury
    Date Received
    January 31, 2022
    Date of Event
    May 15, 2018
    Report Date
    January 31, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE: EXTENSION. PRODUCT ID NEU_ UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE: EXTENSION. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL/LOT #: UNKNOWN. PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEY SWITCHED TO A RECHARGEABLE IMPLANTABLE NEUROSTIMULATOR (INS) ON (B)(6) 2018 AND THE PATIENT THEN EXPERIENCED IMPAIRED DBS EFFECT. ON (B)(6) 2018 IMPEDANCE MEASUREMENTS WERE PERFORMED WHICH SHOWED HIGH ELECTRODE IMPEDANCES FOR ALL CONTACTS FOR ALL CONTACTS, RIGHT BRAIN ELECTRODE. BOTH EXTENSION CABLES WERE REPLACED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1640273 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention