BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 6747826 · Received July 27, 2017

    Report

    Report Number
    2124215-2017-13419
    Event Type
    Death
    Date Received
    July 27, 2017
    Date of Event
    June 30, 2017
    Report Date
    July 1, 2017
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073/S043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    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 PATIENT WAS HAVING AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANTED DUE TO A HISTORY OF VENTRICULAR TACHYCARDIA THAT REQUIRED EXTERNAL DEFIBRILLATION. AFTER THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WERE PLACED, THE PATIENT EXPERIENCED A SHARP DECLINE IN OXYGEN SATURATION AND A RISE IN RHYTHM. ADDITIONAL MEDICAL INTERVENTION MEASURES WERE PERFORMED ON THE PATIENT; HOWEVER, AFTER 50 MINUTES THE PATIENT SUBSEQUENTLY DIED. THE PHYSICIAN STATED THAT THE PATIENT'S DEATH WAS RELATED TO THEIR ILLNESS AND NOT DUE TO ANY BOSTON SCIENTIFIC PRODUCTS OR THE IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528386 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| L| R 0185| 4480