BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5078905 · Received September 15, 2015

    Report

    Report Number
    3004209178-2015-18001
    Event Type
    Injury
    Date Received
    September 15, 2015
    Report Date
    August 21, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7436, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3389S-40, LOT# V033436, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# V029643, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED VIA A MANUFACTURING REPRESENTATIVE THAT A PATIENT WHOSE INDICATION FOR USE WAS PARKINSON'S DUAL AND MOVEMENT DISORDERS HAD AN INFECTED IMPLANTABLE NEUROSTIMULATOR (INS). THE SURGEON WAS UNCLEAR AS TO WHAT HAD LED TO THE INFECTION. A CULTURE WAS OBTAINED AND THE INS AND EXTENSIONS WERE EXPLANTED ON (B)(6) 2015. THE ISSUE WAS RESOLVED. THE DEVICE WOULD BE REPLACED IN THE FUTURE. THE PATIENT WAS ALIVE WITH NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607999 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention