BEUDAMED
    FDA Adverse Event Death Summary report: N

    RELAY

    MDR report key: 794879 · Received December 14, 2006

    Report

    Report Number
    2124215-2006-99523
    Event Type
    Death
    Date Received
    December 14, 2006
    Date of Event
    November 17, 2006
    Report Date
    December 13, 2006
    Manufacturer
    ITM
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONCLUSION: A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT CONTACTED CUSTOMER SERVICE IN ORDER TO PROVIDE A RETURNED PRODUCT KIT FOR THE MEDICAL EXAMINER. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS DEVICE HAS BEEN RETURNED TO OUR RELIABILITY ASSURANCE LABORATORY AND IS CURRENTLY UNDERGOING DETAILED LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER PATIENT COLLAPSED WHILE AT THE GYM AND LATER DIED. THE EMERGENCY ROOM PHYSICIAN EXPRESSED CONCERN THAT A PACEMAKER FAILURE HAD OCCURRED, THUS RESULTING IN THE PATIENT'S DEATH. IT WAS FURTHER NOTED THAT THIS PATIENT WAS SCHEDULED FOR A DEVICE REPLACEMENT THE NEXT WEEK. THE MEDICAL EXAMINER REPORTED THAT THIS PATIENT'S HEART WAS ENLARGED AND THAT THE PT HAD BEEN IN FULL CARDIOPULMONARY ARREST. THE MEDICAL EXAMINER NOTED THAT THE DEVICE WOULD BE RETURNED TO BOSTON SCIENTIFIC'S RELIABILITY ASSURANCE LABORATORY FOR ANALYSIS AND ALSO REQUESTED A COPY OF THE DEVICE ANALYSIS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELAY IMPLANTABLE PULSE GENERATOR DXY ITM 294-03 *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Death