BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5255822 · Received November 30, 2015

    Report

    Report Number
    3004209178-2015-23563
    Event Type
    Malfunction
    Date Received
    November 30, 2015
    Date of Event
    November 4, 2015
    Report Date
    November 5, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 64002, LOT# N319253, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ADAPTER. PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V015069, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V021705, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTH CARE PROVIDER (HCP) REPORTED THAT IMPEDANCES WERE CHECKED AND ALL IMPEDANCES WERE WITHIN NORMAL LIMITS. THE PATIENT铠MEDICATIONS WERE ADJUSTED TO RESOLVE THE SHAKING AND STIFFNESS.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THE PATIENT STARTED SHAKING ON (B)(6) 2015 AND HAD A SUDDEN LOSS OF STIMULATION. THE PATIENT WAS STIFF AND HAVING DIFFICULTY MOVING HIS MOUTH. HE VERIFIED THAT THERAPY WAS ON AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS FULLY CHARGED. THERE WERE NO FALLS OR TRAUMA RELATED TO THE ISSUE. THE PATIENT'S INDICATIONS FOR USE WERE PARKINSON'S DUAL AND MOVEMENT DISORDERS. THE CAUSE OF THE SUDDEN CHANGE WAS NOT REPORTED. NO INTERVENTIONS OR PATIENT OUTCOME WERE REPORTED, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785929 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR