BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2162601 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07175
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 20, 2011
    Report Date
    October 11, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ANOTHER MANUFACTURER'S REPRESENTATIVE CALLED TO REPORT THIS PACING SYSTEM WILL POSSIBLY BE EXTRACTED DUE TO AN INFECTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT THE PACEMAKER WAS RECENTLY EXPLANTED FOR NORMAL BATTERY DEPLETION. THE CHRONIC LEADS REMAIN IN SERVICE WITH THE NEW PACEMAKER. RECORDS INDICATE THIS PACEMAKER SYSTEM WAS NOT PREVIOUSLY EXPLANTED FOR INFECTION, AS THE NON-BOSTON SCIENTIFIC FIELD REPRESENTATIVE MENTIONED WOULD LIKELY HAPPEN BACK IN 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R 4469| 4470