BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 3041197 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01566
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WERE PROGRAMMED TO UNIPOLAR FOR PACING AND SENSING, AND THE PHYSICIAN PLANNED TO EVALUATE THE PATIENT AGAIN IN THREE MONTHS. 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 THIS RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE THAT WAS OVERSENSED, RESULTING IN INAPPROPRIATE ANTI-TACHYCARDIA RESPONSE (ATR) EPISODES. THE LEAD SAFETY SWITCH WAS DISPLAYED ON THE PROGRAMMER FOR THE RA LEAD. NO OUT-OF-RANGE IMPEDANCE MEASUREMENTS WERE NOTED IN THE DAILY MEASUREMENTS, AND THE WEEKLY AVERAGES DID NOT REVEAL A SPECIFIC IMPEDANCE ISSUE. A CHEST X-RAY WAS PERFORMED; THE OUTCOME WAS NOT REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143691 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR 4087| 1297| 4457