BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3092773 · Received May 3, 2013

    Report

    Report Number
    2124215-2013-07354
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 THIS IMPLANTABLE LEAD DISPLAYED LOSS OF MYOCARDIAL CAPTURE RESULTING IN GREATER THAN TWO SECONDS OF ASYSTOLE FOR THE PATIENT. IT WAS ALSO REPORTED THAT LEAD HAD PHYSICAL DAMAGE TO THE CONDUCTOR. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194813 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Hospitalization| L| R 1298| S603| 4470| 4471