BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5243088 · Received November 23, 2015

    Report

    Report Number
    3004209178-2015-23236
    Event Type
    Injury
    Date Received
    November 23, 2015
    Report Date
    October 26, 2015
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37603, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37085-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT # V853915, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37085-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT # V813627, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE (REP) REPORTED THE PATIENT HAD AN OPEN CIRCUIT THAT WAS STILL PRESENT EVEN AFTER THEIR LEADS WERE REVISED. THE PATIENT HAD PREVIOUSLY HAD LEAD REVISION DUE TO OPEN CIRCUIT WITH HIS RIGHT SUBTHALAMIC NUCLEUS. IT WAS INDICATED THAT THE LEAD WAS REPLACED AND NEW LEAD TESTED INTRAOP AND POST OP WITH GOOD IMPEDANCES MEASUREMENT. THIS WAS DONE IN (B)(6) 2015. THE PATIENT WAS SEEN IN THE HEALTH CARE PROVIDER (HCP) OFFICE ON THE DAY OF REPORT AND SHOWING OPEN CIRCUIT AGAIN. THE HCP WAS PLANNING TO REPLACE EXTENSION AND REVIEWED VISUAL INSPECTION OF CONNECTION FROM IMPLANTABLE NEUROSTIMULATOR (INS) TO EXTENSION PRIOR TO REPLACING. IT WAS ALSO REPORTED PATIENT EXPERIENCE SOME DYSARTHRIA WITH HIGH VOLTAGES AND THEIR BRADYKINESIA HAD REDUCED. IT WAS FURTHER PROVIDED THAT THE MANAGING HCP WAS TRYING TO SCHEDULE A FOLLOW UP APPOINTMENT IN THE NEXT WEEK TO GATHER MORE INFORMATION AND CHECK MORE DETAILS REGARDING THE DEVICES. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. THE PATIENT'S INDICATION FOR USE WAS MOVEMENT DISORDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774335 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention