BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3212945 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09046
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS EXPLANTED AND WILL BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UDPATED ONCE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBTED INCREASED PACING THRESHOLDS RESULTING IN A LOSS OF CAPTURE (LOC) WITH ASYSTOLE FOR LESS THAN 2 SECONDS OBSERVED. IT DETERMINED THE LEAD HAD BECOME DISLODGED. THE LEAD WAS EXPLANTED DURING NORMAL DEVICE CHANGE OUT. A NEW LEAD WAS IMPLANTED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313671 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4479

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening| R 7122| 4543| H220| N140| 4479| 4135| 0292