BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3223453 · Received July 12, 2013

    Report

    Report Number
    2124215-2013-09740
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    November 20, 2012
    Report Date
    June 12, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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 HIGH OUT-OF-RANGE (OOR) PACING LEAD IMPEDANCE (PLI) MEASUREMENTS OF GREATER THAN 2500 OHMS. SUBSEQUENTLY, THE RV LEAD DISPLAYED LOSS OF MYOCARDIAL CAPTURE (LOC) BUT THE IMPEDANCE MEASUREMENT WAS WITHIN NORMAL RANGE. THIS RV LEAD WAS SURGICALLY ABANDONED WHERE IT WAS CAPPED AND WAS REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321538 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R 1294| 4469| 4087