BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 1953968 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24212
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE LEAD EXPERIENCED A LEAD SAFETY SWITCH. THIS LEAD WAS FOUND IN UNIPOLAR CONFIGURATION. STORED ATRIAL TACHYCARDIA RESPONSE EVENTS DUE TO NOISE WERE OBSERVED. THRESHOLDS WERE REPORTED AS VARIABLE. THE PATIENT REPORTED THEY RECENTLY MOVED IN CLOSE PROXIMITY TO A POWER PLANT. THE PATIENT HAD REPORTED SHORTNESS OF BREATH. BOSTON SCIENTIFIC TECHNICAL SERVICES WAS CONTACTED WHOM SUGGESTED REPEATING THRESHOLD TESTS AT 6 VOLTS AND STEPPING ALL THE WAY DOWN. CURRENTLY, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR S603| 4087| 4086