BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 8819403 · Received July 23, 2019

    Report

    Report Number
    2124215-2019-14240
    Event Type
    Injury
    Date Received
    July 23, 2019
    Date of Event
    April 10, 2019
    Report Date
    November 9, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DTB
    UDI-DI
    00802526397721
    PMA / PMN Number
    P960006/S005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO INDICATE THAT IN H6, CODE 3191 IS USED TO CAPTURE SURGICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED LOW, OUT-OF-RANGE PACING IMPEDANCE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE LEAD WAS SURGICALLY ABANDONED AT DEVICE CHANGEOUT DUE TO NOISE, OVERSENSING, PACING INHIBITION, AND PACING IMPEDANCE LESS THAN 200 OHMS. HIGH PACING THRESHOLDS AND LOSS OF CAPTURE WITH NO ASYSTOLE WAS NOTED. THE PHYSICIAN SAID THAT THE LEAD ISSUES HAD BEEN ONGOING FOR OVER A YEAR BUT THEY COULD NOT DETERMINE WHAT WAS CAUSING THE CLINICAL OBSERVATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED LOW, OUT-OF-RANGE PACING IMPEDANCE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE LEAD WAS SURGICALLY ABANDONED AT DEVICE CHANGEOUT DUE TO NOISE, OVERSENSING, PACING INHIBITION, AND PACING IMPEDANCE LESS THAN 200 OHMS. HIGH PACING THRESHOLDS AND LOSS OF CAPTURE WITH NO ASYSTOLE WAS NOTED. THE PHYSICIAN SAID THAT THE LEAD ISSUES HAD BEEN ONGOING FOR OVER A YEAR BUT THEY COULD NOT DETERMINE WHAT WAS CAUSING THE CLINICAL OBSERVATIONS.

    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

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED LOW, OUT-OF-RANGE PACING IMPEDANCE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612461 FLEXTEND PERMANENT PACEMAKER ELECTRODE DTB BOSTON SCIENTIFIC CORPORATION 4086 00802526397721

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R