BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3953815 · Received July 23, 2014

    Report

    Report Number
    2124215-2014-14216
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 23, 2013
    Report Date
    June 23, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 WHILE EVALUATING THE PACEMAKER AND RIGHT ATRIAL (RA) LEAD FOR DECREASED PACING IMPEDANCE MEASUREMENTS, THE CLINICIAN NOTED STORED EPISODES OF NOISE ON BOTH THE RA AND RIGHT VENTRICULAR (RV) LEADS. ON THE RV CHANNEL THE NOISE WAS OVERSENSED AND LED TO PACING INHIBITION WITH GREATER THAN TWO SECONDS OF ASYSTOLE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND AFTER REVIEW OF THE ELECTROGRAMS, STATED THAT THE NOISE APPEARED TO BE EXTERNAL. THE CLINICIAN IDENTIFIED THAT THE ELECTROGRAM WAS FROM ONE YEAR EARLIER WHEN THE PATIENT WAS IN A PROCEDURE. THUS NO FURTHER PROGRAMMING CHANGES OR INVESTIGATION REGARDING THE NOISE WAS PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431960 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR 1294| 4470| 4469