BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3041240 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01316
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD HAS NOT BEEN RETURNED. 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 PATIENT EXPERIENCED A SYNCOPAL EPISODE. DURING THE DEVICE CHECK, DAMAGE TO THE RIGHT VENTRICULAR (RV) LEAD WAS NOTED. AS A FRACTURE WAS SUSPECTED, THE LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143570 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R