BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3211098 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09798
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 25, 2013
    Report Date
    November 5, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS PROGRAMMED TO BIPOLAR AND THE PATIENT WILL CONTINUE TO BE MONITORED THROUGH ROUTINE FOLLOW-UPS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    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

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS LEAD EXHIBITED LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. AN INVASIVE PROCEDURE WAS PERFORMED. THIS LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE CHECK AN OUT OF RANGE PACING IMPEDANCE MEASUREMENT WAS NOTED ON THIS RIGHT VENTRICULAR (RV) LEAD. THE DEVICE LOGBOOK REVEALED NUMEROUS INAPPROPRIATE TACHYCARDIA EPISODES WERE STORED DUE TO OVERSENSED NOISE. NOISE WAS ABLE TO BE RECREATED IN CLINIC. IN CLINIC ALL MEASUREMENTS WERE ACCEPTABLE. IT WAS REPORTED THE PATIENT IS NOT PACER DEPENDENT AND THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311319 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R 4088| 4470| 1291