BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5147760 · Received October 14, 2015

    Report

    Report Number
    3004209178-2015-20532
    Event Type
    Malfunction
    Date Received
    October 14, 2015
    Date of Event
    June 21, 2011
    Report Date
    September 17, 2015
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# V761180, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. (B)(4)

    Description of Event or Problem · 1

    A CONSUMER WHOSE INDICATION FOR USE WAS PARKINSON'S DUAL AND MOVEMENT DISORDERS REPORTED THAT THE INS (IMPLANTABLE NEUROSTIMULATOR) HAD MIGRATED A BIT. THE PATIENT STATED THAT HEALTHCARE PROVIDER HAD ASSESSED IT AND SAID IT WAS OK. THE PATIENT ALSO NOTED HIS SYMPTOMS HAD SHIFTED SLIGHTLY FROM RIGHT SIDE TO LEFT SIDE. THE CHANGE IN THERAPY/SYMPTOM WAS CONSIDERED GRADUAL. TWO WEEKS LATER, HCP REPORTED THAT THEY WERE NOT SURE THE CAUSE OF INS MIGRATION. IT WAS ONLY PATIENT SUBJECTIVE COMPLAINT AND THERE WAS NO INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678184 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR