BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3053261 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05372
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 20, 2013
    Report Date
    February 10, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE PORTION OF THE LEAD THAT WAS RETURNED WAS ANALYZED. THE LEAD HAD BEEN SEVERED 18 CENTIMETERS FROM THE IS-1 TERMINAL PIN. SET SCREW MARKS WERE NOTED ON TERMINAL PIN & TERMINAL RING. THE RETURNED PORTION OF THE LEAD PASSED ELECTRICAL TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RECENTLY IMPLANTED RIGHT VENTRICULAR (RV) LEAD PRESENTED TO THE EMERGENCY ROOM. THE PATIENT WAS EXPERIENCING SYMPTOMS DUE TO BEING IN COMPLETE HEART BLOCK. UPON INTERROGATION, THE LEAD DISPLAYED HIGH PACING THRESHOLDS AND LOSS OF CAPTURE. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THAT THE LEAD WAS ALSO OVERSENSING. THE PATIENT WAS SEEN FOR A LEAD REVISION PROCEDURE WHERE THE LEAD WAS REPOSITIONED AND REMAINS IN SERVICE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT A PORTION OF THE LEAD WAS EXPLANTED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156883 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R