BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4955932 · Received July 31, 2015

    Report

    Report Number
    2124215-2015-10015
    Event Type
    Death
    Date Received
    July 31, 2015
    Date of Event
    July 9, 2015
    Report Date
    July 9, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS PRESENTED BACK TO THE ELECTROPHYSIOLOGY (EP) LABORATORY ON (B)(6) 2015. THE SYSTEM WAS EXPLANTED DUE TO INFECTION. SUBSEQUENTLY, THE LOCAL REPRESENTATIVE WAS INFORMED THAT THIS PATIENT HAD DIED ON (B)(6) 2015. THE CAUSE OF DEATH WAS ATTRIBUTED TO RESPIRATORY ARREST. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR SEVERE SLEEP APNEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501290 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| H| L| R 0158| 4470| 4136| 4518| N118