BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3212626 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09702
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURN OF THE PRODUCT IS NOT EXPECTED. 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 DURING THE ATTEMPTED IMPLANT OF THIS IMPLANTABLE DEFIBRILLATION LEAD, THE LEAD WAS ATTEMPTED TO BE PLACED IN THREE SEPARATE LOCATIONS ALONG THE RIGHT VENTRICULAR (RV) APEX. PRIOR TO HELIX EXTENSION IN ALL LOCATIONS, STABLE LEAD MEASUREMENTS WERE OBSERVED. FOLLOWING HELIX EXTENSION, THE LEAD EXHIBITED INCREASED THRESHOLD MEASUREMENTS, LOSS OF CAPTURE (LOC) AND HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,500 OHMS. THE PHYSICIAN NOTED THAT IT TOOK A MINIMUM OF 20 TURNS TO EXTEND THE HELIX. THE LEAD WAS REMOVED AND ANOTHER LEAD WAS PLACED INTO THE SHEATH, WHEN THE PATIENT'S BLOOD PRESSURE DROPPED. FLUOROSCOPIC IMAGING OF THE HEART SHOWED NO MOVEMENT. THE PATIENT REQUIRED CARDIOPULMONARY RESUSCITATION (CPR) AND WAS INTUBATED. AN ECHOCARDIOGRAM WAS PERFORMED AND A PERFORATION AND CARDIAC TAMPONADE WAS OBSERVED. A PERICARDIOCENTESIS WAS PERFORMED. AFTER THE PATIENT STABILIZED, A NEW LEAD WAS SUCCESSFULLY IMPLANTED WITHOUT INCIDENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312860 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R E142| 0296| 4469