BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4486647 · Received February 5, 2015

    Report

    Report Number
    3004209178-2015-01801
    Event Type
    Injury
    Date Received
    February 5, 2015
    Report Date
    January 19, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), PRODUCT TYPE EXTENSION. PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), PRODUCT TYPE EXTENSION. PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6). PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3387S-40, LOT# V093181, IMPLANTED: 2008-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 3387S-40, LOT# V093181, IMPLANTED: 2008-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS HAVING A REVISION OF THE LEFT EXTENSION AND POSSIBLY THE LEFT LEAD ON 2015-(B)(6). THE MANUFACTURING REPRESENTATIVE WAS NOT SURE WHEN THE ISSUE WITH THE SYSTEM STARTED OR IF THERE WERE ANY FALLS OR TRAUMA. NO SYMPTOMS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82999 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention