BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 2080646 · Received May 6, 2011

    Report

    Report Number
    2124215-2011-08058
    Event Type
    Death
    Date Received
    May 6, 2011
    Date of Event
    January 23, 2004
    Report Date
    April 8, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE CURRENT BOSTON SCIENTIFIC FIELD REPRESENTATIVE ASSOCIATED WITH THE IMPLANTING HEALTH CARE PROVIDER HAS BEEN CONTACTED FOR ANY ADDITIONAL AVAILABLE INFORMATION, BUT AS OF THIS TIME, HAS NOT OBTAINED ANY ADDITIONAL INFORMATION. THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE PATIENT'S SON ALLEGING THAT THIS RIGHT VENTRICULAR (RV) LEAD MAY HAVE CONTRIBUTED TO THE PATIENT'S DEATH. THE ALLEGATION WAS RECEIVED 86.5 MONTHS AFTER THE PATIENT'S DEATH. THE SON SUBSEQUENTLY REPORTED HIS MOTHER, WHO ALSO IS DECEASED, HAD SPOKE OF THE PATIENT RECEIVING SHOCKS ON SEPARATE OCCASIONS WHEN WALKING OVER THE SAME SPOT IN A RESTAURANT ABOUT TWO OR THREE YEARS AFTER DEVICE IMPLANT. THE SON ALSO REPORTED THAT HIS MOTHER BELIEVED THE PATIENT'S DEATH WAS DUE TO THE SHOCKS. THE SON HAD NO ADDITIONAL INFORMATION AS TO WHETHER THE SHOCKS WERE INAPPROPRIATE OR APPROPRIATE, AND SAID THAT HE HAD NO FIRST-HAND KNOWLEDGE OF THE ISSUE. A REVIEW OF BOSTON SCIENTIFIC DATABASES SHOWED ONE REPORTED ISSUE DURING A NORMAL DEVICE CHECK SEVEN WEEKS AFTER DEVICE IMPLANT FOR A DIVERTED SHOCK EPISODE DUE TO NOISE. CLINICAL INVESTIGATION WAS ABLE TO CREATE A SLIGHT AMOUNT OF NOISE WITH ARM MOVEMENTS AT THAT TIME; THE PHYSICIAN ELECTED TO MONITOR THE DEVICE AND LEAD IN RESPONSE TO THE OBSERVATIONS, AS LEAD MEASUREMENTS WERE NORMAL AND STABLE, AND THERE WERE NO OTHER EPISODES. THERE IS NO RECORD OF THE LEAD HAVING BEEN RETURNED TO BOSTON SCIENTIFIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0155

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death 1850| 0155