BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3043322 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-03759
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 28, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT HAD SUFFERED A FALL THAT WAS NOT RELATED TO DEVICE OR LEAD FUNCTION. FOLLOWING WHICH, PACING IMPEDANCES HAD INCREASED TO GREATER THAN 3000 OHMS AND THERE WAS EVIDENCE OF NOISE RESULTING IN INAPPROPRIATE EPISODES OF ATRIAL TACHY RESPONSE (ATR). THERE WERE NO ADVERSE PATIENT EFFECTS RELATED TO THE DEVICE OR LEAD. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT ATRIAL DISCRIMINATORS WERE PROGRAMMED OFF, AND THE PHYSICIAN WILL CONTINUE TO MONITOR THE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146204 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4472

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR S403| 4473| 4472| 4271| 1230| 0180| MISMATCH| E030