BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2911780 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16188
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 WITH THIS RIGHT VENTRICULAR (RV) LEAD PRESENTED TO THE HOSPITAL WITH EPISODES OF SYNCOPE. THE MONITOR STRIPS REVEALED INTERMITTENT RV CAPTURE AT AN OUTPUT OF 4 VOLTS AT 0.5 MILLISECONDS. THE RV OUTPUTS WERE INCREASED TO MAXIMUM OUTPUT AND THERE WAS CONSISTENT CAPTURE. THIS PATIENT UNDERWENT A REVISION PROCEDURE AND THIS LEAD WAS SURGICALLY CAPPED AND ABANDONED. THERE WAS NO EVIDENCE OF A LEAD FRACTURE OR INSULATION ISSUE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16922 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R 4137| S602| 4087| 1297| 4088