BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2910913 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16102
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    October 30, 2012
    Report Date
    November 15, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH RIGHT VENTRICULAR (RV) LOSS OF CAPTURE AND AN ESCAPE RHYTHM OF 35 BPM. UPON INTERROGATION THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NO CAPTURE AT MAXIMUM OUTPUT AND THE DAILY MEASUREMENT REVEALED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT FOR THE LAST TWO WEEKS. A FLUOROSCOPY IMAGE DETERMINED THAT THE RV LEAD WAS FRACTURED IN THE POCKET. SUBSEQUENTLY THE 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
    16945 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| L| R 4087| 1270| 1296| 4034| 5554