BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 4150872 · Received October 8, 2014

    Report

    Report Number
    2124215-2014-16760
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE LEAD WAS DISCARDED. AS THE LEAD WILL NOT BE RETURNED FOR ANALYSIS, THE CLINICAL OBSERVATIONS CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. REQUEST HAD BEEN MADE FOR THIS PRODUCT TO BE RETURNED. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THAT THIS RIGHT ATRIAL (RA) LEAD WAS EXPLANTED. ADDITIONAL INFORMATION INDICATED THAT THIS LEAD HAD DISLODGED. THIS RA LEAD WAS REPLACED WITH A NEW LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD HAD DISLODGED. ADDITIONAL INFORMATION RECEIVED FROM THE FIELD REPRESENTATIVE CONFIRMED THE DISLODGEMENT. THIS RA LEAD WAS EXPLANTED AND WAS REPLACED WITH A NEW LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633218 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| L| R 4087| 4088| K173| 4136