BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3052757 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05357
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LOSS OF CAPTURE (LOC) WAS OBSERVED. ALL OTHER MEASUREMENTS WERE STABLE. A REQUEST FOR ADDITIONAL INFORMATION WAS SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO ASYSTOLE OBSERVED. THE ROOT CAUSE WAS NOT DETERMINED. OUTPUTS WERE INCREASED TO ENSURE A HIGHER SAFETY MARGIN. ALL OTHER TEST WERE WITHIN NORMAL LIMITS. NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156298 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR 4469| 4470| S603