BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2910535 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15425
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 12, 2012
    Report Date
    November 13, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    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 THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE, OVERSENSING RESULTING IN GREATER THAN 2 SECONDS OF ASYSTOLE, LOSS OF CAPTURE AND AN INCREASE IN PACING IMPEDANCES. THIS PATIENT UNDERWENT A REVISION PROCEDURE AND THIS PRODUCT WAS SURGICALLY CAPPED AND ABANDONED. IT WAS ALLEGED THAT THIS LEAD HAD FRACTURED; HOWEVER, A VISUAL FRACTURE WAS NOT OBSERVED DURING THE REVISION PROCEDURE. NO FURTHER COMPLICATIONS OR ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16684 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R 1290| 4087| 4086