BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2913769 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00364
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PHYSICIAN

    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS ALSO RIGHT VENTRICULAR (RV) LOSS OF CAPTURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING OF NOISE LEADING TO PACING INHIBITION. IT WAS NOTED THAT THE PATIENT HAD AN UNDERLYING RATE BETWEEN 40 AND 45 BPM AND IS NOT PACEMAKER DEPENDENT. THE NOISE WAS ABLE TO BE RECREATED WITH ARM MOVEMENTS. LOW R-WAVES AND INTERMITTENT LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENTS WERE ALSO OBSERVED, A CLAVICLE CRUSH WAS SUSPECTED. SUBSEQUENTLY A REVISION PROCEDURE WAS PERFORMED WHERE THE RV LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19707 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R 4086| S606| 4087