BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5242587 · Received November 23, 2015

    Report

    Report Number
    6000153-2015-00265
    Event Type
    Malfunction
    Date Received
    November 23, 2015
    Date of Event
    April 9, 2015
    Report Date
    November 2, 2015
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7428, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387S-40, LOT# V011938, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THERE WERE NO HOSPITALIZATIONS WERE RELATED TO THIS EVENT. ETIOLOGY WAS THE LEAD BEING VERY TIGHT SITTING UPRIGHT, MILD FLUCTUANCE AT INFERIOR EDGE.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL FROM A CLINICAL STUDY REPORTED THAT THE LEAD WAS VERY TIGHT, SITTING UPRIGHT AND THERE WAS A MILD FLUCTUANCE AT INFERIOR EDGE. SIGNS AND SYMPTOMS INCLUDED THE AREA WHERE THE BATTERY WAS IN THE CHEST WAS VERY LOOSE. NO DIAGNOSTIC TEST PERFORMED AND NO ACTIONS WERE TAKEN. THE EVENT WAS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772454 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3387S-40 V011938

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR