BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3213097 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09884
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 6, 2013
    Report Date
    June 3, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE ATTEMPTS, NO FURTHER INFORMATION COULD BE OBTAINED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE REPLACEMENT PROCEDURE, THIS CHRONIC RIGHT VENTRICULAR LEAD WAS SURGICALLY ABANDONED DUE TO AN UNKNOWN LEAD ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312179 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R 4457| (B)(4)| 4480| MISMATCH