BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2162607 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-08073
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF FURTHER INFORMATION, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR LEAD PRESENTED TO THE EMERGENCY ROOM. INTERROGATION REVEALED INTERMITTENT RIGHT VENTRICULAR LOSS OF CAPTURE OCCURRING EVERY OTHER BEAT. NO LOSS OF CAPTURE GREATER THAN TWO SECONDS WAS REVEALED. THE PATIENT REPORTED SYMPTOMS OF DIZZINESS BUT NO SYNCOPE AND IS HEMODYNAMICALLY STABLE. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED AND RECOMMENDED VERIFYING RIGHT VENTRICULAR LEAD INTEGRITY AS THE IMPEDANCE MEASUREMENTS HAVE INCREASED, HOWEVER, REMAIN WITHIN LABELING SPECIFICATIONS. A DECISION WILL BE MADE REGARDING LEAD REVISION IN THE NEAR FUTURE. ADDITIONAL INFORMATION WAS RECEIVED. NO ASYSTOLE GREATER THAN TWO SECONDS WAS REVEALED. IT WAS THOUGHT THIS WAS A LEAD ISSUE DUE TO THE INCREASING IMPEDANCE MEASUREMENTS. THE REVISION PROCEDURE IS SCHEDULED. NO FURTHER PATIENT SYMPTOMS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Other 4457| 1298| 4087