BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3944240 · Received July 18, 2014

    Report

    Report Number
    3004209178-2014-13236
    Event Type
    Injury
    Date Received
    July 18, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# VA0F2FU, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3387S-40, LOT# VA0F26B, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED. THE DEVICE WAS EXPLANTED ON (B)(6) 2014. IT WAS THE RIGHT DEVICE. IT WAS LATER REPORTED THAT THE BATTERY WAS REMOVED DUE TO AN INFECTION. THE BATTERY HAD NOT BEEN REPLACED BUT WOULD BE ONCE THE INFECTION WAS GIVEN TIME TO CLEAR. IT WAS CONFIRMED ONLY THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REMOVED AND LEADS/EXTENSIONS REMAINED IMPLANTED AND WOULD BE USED ONCE THE INFECTION CLEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422977 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention