BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4765097 · Received May 12, 2015

    Report

    Report Number
    3004209178-2015-08926
    Event Type
    Injury
    Date Received
    May 12, 2015
    Report Date
    April 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
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# V101646, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A40, SERIAL# (B)(), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V108523, IMPLANTED: (B)(6) 2008,PRODUCT TYPE: LEAD. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE; EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT NOTICED SOME TENDERNESS AROUND THE TOP OF THE IMPLANTABLE NEUROSTIMULATOR (INS). THE INS WAS IMPLANTED WITH A POCKET ADAPTOR BENEATH IT. THE INS WAS NEARING END OF LIFE AND THE PATIENT¿S HEALTHCARE PROFESSIONAL (HCP) DECIDED TO REPLACE THE INS AT THE SAME TIME THE INS PLACEMENT WAS REVISED. DURING THE REVISION, A NEW POCKET WAS MADE ABOUT 1.5 TO 2 CM BELOW THE PREVIOUS POCKET. IMPEDANCES WERE MEASURED TO BE FINE AND THE INS POCKET WAS CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308659 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention