BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3211058 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08318
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 1, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED LOSS OF CAPTURE (LOC) AS WELL AS OUT-OF-RANGE (OOR) LOW PACING IMPEDANCES OF LESS THAN 200 OHMS. AS A RESULT THE LEAD WAS SURGICALLY ABANDONED. DURING THE EXPLANT PROCEDURE THE PHYSICIAN TRIED TO RECREATE THESE ISSUES AND COULD NOT. SINCE IT WAS UNDETERMINED IF IT WAS A LEAD OR DEVICE ISSUE, THE PHYSICIAN CHOSE TO EXPLANT THE DEVICE, ABANDON THE LEAD AND IMPLANT A NEW SYSTEM. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION BECAME AVAILABLE THAT THIS RIGHT ATRIAL (RA) LEAD ALSO EXHIBITED NOISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311034 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R 0184| 4086| E053| T125