BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3210242 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08465
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 13, 2013
    Report Date
    January 28, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DTB
    PMA / PMN Number
    P960006/S005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE. AT THIS TIME THERE IS NO FURTHER INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE LOCAL AREA SALES REPRESENTATIVE INDICATED THAT NO INTERVENTION PLANNED TO BE PERFORMED REGARDING THIS ISSUE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD WAS EXHIBITING NOISE AND HIGH PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. THE DEVICE HAD PREVIOUSLY BEEN PROGRAMMED TO VVI MODE DUE TO THE PATIENT'S ATRIAL FIBRILLATION (AF). ISOMETRICS WERE PERFORMED AND A VARIATION IN IMPEDANCE MEASUREMENTS BETWEEN 700-1,600 OHMS COULD BE GENERATED. IT WAS UNLIKELY ANY INTERVENTION WOULD BE PERFORMED SINCE THE RA LEAD WAS NOT BEING USED FOR THERAPY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311541 FLEXTEND IMPLANTABLE LEAD DTB BOSTON SCIENTIFIC CORPORATION 4086
    311562 FLEXTEND IMPLANTABLE LEAD DTB BOSTON SCIENTIFIC CORPORATION 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Hospitalization| R 0157| 1853| 4086| E163| T180| 4086| T180| 1853| E163| 0157