BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 5061259 · Received September 8, 2015

    Report

    Report Number
    2124215-2015-11544
    Event Type
    Death
    Date Received
    September 8, 2015
    Date of Event
    August 24, 2015
    Report Date
    October 6, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT UNDERWENT AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANT PROCEDURE. THIS RIGHT VENTRICULAR (RV) LEAD WAS SUCCESSFULLY IMPLANTED. A RIGHT ATRIAL (RA) LEAD WAS THEN ATTEMPTED BUT WAS NOT IMPLANTED AS A SUITABLE POSITION WAS NOT IDENTIFIED. THE PHYSICIAN OPTED TO USE ANOTHER COMPANY'S RA LEAD; MULTIPLE POSITIONS WERE TRIED BEFORE A LOCATION HAVING 0.8 MV P-WAVES WAS FOUND AND USED. THE PATIENT'S RHYTHM WAS ATRIAL SENSING VENTRICULAR PACING. THE PATIENT'S HEART RATE THEN ELEVATED INTO THE 100'S WITH A DROP IN BLOOD PRESSURE. A PERICARDIAL EFFUSION WAS NOTED AND THE PATIENT CODED; IT WAS UNKNOWN WHICH LEAD CAUSE THE PERFORATION THAT LEAD TO THE EFFUSION. VENTRICULAR FIBRILLATION (VF) WAS TREATED BY THE DEVICE AND BY EXTERNAL SHOCK THERAPY. RESUSCITATIVE EFFORTS WERE PERFORMED AND AFTER APPROXIMATELY ONE HOUR PULSELESS ELECTRICAL ACTIVITY WAS REPORTED. THE BRADY AND TACHY THERAPIES FROM THE DEVICE WERE TURNED OFF. THE ATTEMPTED RIGHT ATRIAL (RA) LEAD WAS GOING TO BE RETURNED FOR ANALYSIS, BUT ALL OTHER PRODUCTS REMAINED WITH THE PATIENT. THERE WERE NO ALLEGATIONS REPORTED, BUT AN ANALYSIS LETTER FOR THE ATTEMPTED RIGHT ATRIAL (RA) LEAD WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593329 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| H| L| R