BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3211332 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09022
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE POCKET WAS REOPENED AND THE LEADS WERE RECONNECTED TO THE CORRECT PORTS IN THE DEVICE HEADER. AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE. 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 THE PATIENT IMPLANTED WITH THIS PACEMAKER, RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS PRESENTED TO THE HOSPITAL FOR AN UNRELATED PROCEDURE. DURING THE PRE-OPERATIVE CHECK, THE PHYSICIAN DETERMINED THAT THE LEADS WERE REVERSED IN THE DEVICE HEADER. AN INVASIVE PROCEDURE WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310226 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R 4457| 1298| S603| 4470