BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2173646 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11553
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PACEMAKER WAS REMOVED FROM SERVICE BUT THIS RV LEAD REMAINS IN SERVICE. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED. THE INVESTIGATION REMAINS OPEN AT THIS TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PULSE GENERATOR IN ASSOCIATION WITH THIS RIGHT VENTRICULAR (RV) LEAD MAY HAVE CAUSED OR CONTRIBUTED TO THE NOISE INDUCED PACEMAKER INHIBITION. THE PATIENT DID EXPERIENCE SYNCOPE AND ASYSTOLE GREATER THAN 2 SECONDS AS A RESULT. TROUBLESHOOTING BY THE PHYSICIAN COULD NOT IDENTIFY ANY LEAD ISSUE SUCH AS FRACTURE OR BREAK IN EITHER THE RV LEAD OR THE DEVICE HEADER. THERE WAS NO STATED EVIDENCE OF A CONNECTION ISSUE. IMPEDANCES WERE WITHIN NORMAL LIMITS ALSO, TESTED WITH THE PACING SYSTEM ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention 1194| S601| 4471