BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2905532 · Received January 9, 2013

    Report

    Report Number
    2124215-2013-00286
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    October 1, 2012
    Report Date
    January 24, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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 EXPERIENCED SYNCOPE FOR AN UNKNOWN REASON WHILE ON DIALYSIS. UPON INTERROGATION, THE RIGHT VENTRICULAR (RV) LEAD WAS FOUND TO HAVE OVERSENSED NOISE WHICH LED TO INAPPROPRIATE STORED VENTRICULAR TACHYCARDIA (VT) EPISODE EARLIER THAT MORNING. HOWEVER, IT WAS NOTED THAT THE OVERSENSING EPISODE TIME DID NOT CORRELATE WITH THE TIME OF THE SYNCOPE, THUS IT WAS BELIEVED THAT THEY WERE UNRELATED. THE FIELD REPRESENTATIVE STATED THAT THERE WAS ALSO NO SUSTAINED ASYSTOLIC PERIODS AND NO PROGRAMMING CHANGES WERE MADE TO THE SYSTEM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED AND THE DEVICE WAS EXPLANTED DUE TO CONTINUED INTERMITTENT SENSING AND DECREASING R WAVE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12194 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R 4470| 1297| 4088| 4244