BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3052727 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05070
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 1, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE WHICH WAS OVERSENSED AND RESULTED IN PACING INHIBITION. ASYSTOLE WAS NOTED FOR GREATER THAN TWO SECONDS AND THE PATIENT EXPERIENCED A SYNCOPAL EPISODE. IT WAS ALSO REPORTED THE PATIENT EXPERIENCED A SEIZURE AND HEAD INJURY DUE TO THE ASYSTOLE. IT WAS DETERMINED THE LEAD WAS FRACTURED DUE TO CLAVICULAR CRUSH. AN INVASIVE PROCEDURE WAS PERFORMED. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154808 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L| R S606| 1194| 1174| 281-05| (B)(4)| 4469| 4456