BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3922031 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-12391
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS NOT EXPECTED TO BE RETURNED. 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 THIS PACEMAKER WITH THIS RIGHT ATRIAL (RA) LEAD EXHIBITED LOW, OUT-OF-RANGE (OOR), PACING LEAD IMPEDANCE MEASUREMENT OF LESS THAN 200 OHMS. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED AND LEAD WAS ABANDONED SURGICALLY. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE CAUSE OF THE OOR IMPEDANCE MEASUREMENT WAS NOT DETERMINED. FLUOROSCOPY RESULT WAS UNREMARKABLE AND THE LEAD WAS NOT TESTED WITH THE PACING SYSTEM ANALYZER (PSA). A NEW DEVICE AND RA LEAD WERE SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401068 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R 1290| 4469| 4087| 4086| K273