BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3251980 · Received July 29, 2013

    Report

    Report Number
    2124215-2013-12066
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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 IMPLANTED WITH THIS RIGHT VENTRICULAR (RV) LEAD EXPERIENCED VIGOROUS COUGHING EPISODES POST POCKET CLOSURE ON THE SAME DAY OF IMPLANT. THE RV LEAD EXHIBITED UNDERSENSING AND INTERMITTENT SENSING. THE RV LEAD HAD DISLODGED. A REVISION PROCEDURE WAS PERFORMED. THE LEAD WAS SUCCESSFULLY REPOSITIONED WITH ALL MEASUREMENTS WITHIN NORMAL RANGE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353469 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R 4087| 4088| K063