BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 3911770 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-11611
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD WAS SUSPECTED TO HAVE MOVED WITH OPEN HEART SURGERY. THE LEAD HAD LOSS OF SENSING FROM 2.3 MILLIVOLTS (MV) TO 0.3 MV P-WAVES AND THRESHOLDS WENT UP FROM 1.5 MV AT 0.4 MILLISECONDS (MS) TO 3.4 MV AT 1.0 MS. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE AMPLITUDE WAS INCREASED TO GIVE THE PATIENT A SAFETY MARGIN IF PACING WAS REQUIRED. FURTHERMORE, THE FIELD REPRESENTATIVE DID NOT KNOW IF THE POSITION WAS CONFIRMED THROUGH X-RAY. THE RA LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391771 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 4087| K063| 4088