BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXTEND

    MDR report key: 2091916 · Received May 17, 2011

    Report

    Report Number
    2124215-2011-08669
    Event Type
    Death
    Date Received
    May 17, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO ALLEGATION AGAINST THIS LEAD, WHICH IS TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD WAS ASSOCIATED WITH A PATIENT DEATH DURING THE IMPLANT PROCEDURE. THE PATIENT WAS DIAGNOSED WITH INTERMITTENT COMPLETE HEART BLOCK, AND HAD STENTS IMPLANTED PRIOR TO THIS PROCEDURE. IT WAS REPORTED THAT A RIGHT VENTRICULAR (RV) LEAD WAS INITIALLY SUCCESSFULLY PLACED, BUT THE PHYSICIAN ELECTED TO REPOSITION IT DUE TO LEAD MOVEMENT. THE PATIENT'S BLOOD PRESSURE DROPPED, AND THIS RA LEAD WAS PLACED WHILE AN ECHOCARDIOGRAM WAS PERFORMED. A PERICARDIAL EFFUSION WAS CONFIRMED, AND 175 CUBIC CENTIMETERS OF BLOOD WAS WITHDRAWN. THE PATIENT BECAME ASYSTOLIC WHEN THE TEMPORARY PACING WIRE SUBSEQUENTLY WAS REMOVED. FLUOROSCOPY SHOWED A PERFORATION, AND THE RV LEAD WAS PULLED BACK AND ANCHORED IN A MORE PROXIMAL POSITION WITH GOOD CAPTURE. DURING REPOSITIONING OF THE RA LEAD, THE PATIENT EXPERIENCED A VENTRICULAR TACHYCARDIA AND A CODE WAS CALLED. DURING THE CODE, IT WAS NOTED THAT THE PATIENT'S BLOOD PRESSURE WAS VERY LOW, AND THE LEFT VENTRICLE WAS NOT BEATING ALTHOUGH THE PACING WAS CAPTURING THE OTHER HEART CHAMBERS. THE CODE WAS RUN FOR SOME TIME, BUT THE PATIENT DID NOT RECOVER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 4086| 4087