BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1954148 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24211
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 15, 2010
    Report Date
    August 10, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT WILL BE UPDATED SHOULD FURTHER INFORMATION BE RECEIVED.

    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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT THIS RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED AND REPLACED DUE TO NOISE OVERSENSING CAUSING ATRIAL TACHY RESPONSE (ATR) AND PACING INHIBITION. THE DEVICE WAS EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R S603| 4087