BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3043128 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-01857
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 17, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    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 DISPLAYED PACING IMPEDANCES OF GREATER THAN 2500 OHMS. IT WAS INDICATED THAT A LEAD SAFETY SWITCH HAD OCCURRED. RV CAPTURE WAS UNABLE TO BE OBTAINED AT MAXIMUM OUTPUT. THE PATIENT WAS SEEN FOR A LEAD REVISION PROCEDURE WHERE THE LEAD WAS SURGICALLY ABANDONED. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146239 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R 4088| S601