BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 3911790 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-11931
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 RIGHT ATRIAL (RA) LEAD WAS DISLODGED. AI INDICATES THAT THE LEAD WAS DISLODGED DURING THE EXPLANT PROCEDURE OF THE RIGHT VENTRICULAR (RV) LEAD. THIS LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391671 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR MISMATCH| S602| 4087| K173| 1291| 4088| 4076