BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2040742 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00838
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED. AT THIS TIME, OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PACER DEPENDENT PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD WAS HOSPITALIZED AFTER INTERMITTENT LOSS OF CAPTURE (LOC) ON BOTH THE RV AND LEFT VENTRICULAR (LV) LEAD. THE RV LEAD ALSO DISPLAYED HIGH PACING THRESHOLDS. A REVISION PROCEDURE WAS PERFORMED DURING WHICH THE RV LEAD WAS CUT AND CAPPED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R 4592| 4591| 4047| 0185| 4086| (B)(4)| 4087| (B)(4)| 1296| 0184