BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 1962278 · Received January 18, 2011

    Report

    Report Number
    2124215-2011-00863
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    December 24, 2010
    Report Date
    February 15, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE OUT OF RANGE IMPEDANCE MEASUREMENTS WERE UNSUCCESSFUL. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT HIGH OUT OF RANGE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE MEASUREMENTS WERE OBSERVED ONE DAY POST IMPLANT. INCREASING THRESHOLD MEASUREMENTS WERE ALSO REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT A RV LEAD REVISION PROCEDURE WAS PERFORMED AS A RESULT OF THE HIGH OUT OF RANGE THRESHOLD MEASUREMENTS. IT WAS REPORTED THAT THIS WAS A RESULT OF THE PATIENT TAKING A LARGE DOSE OF SOTALOL. THIS RV LEAD WAS EXPLANTED AND A NEW RV LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE 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 72 YR Required Intervention 4542| H120| 4135| 4087