BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSURE SENSE

    MDR report key: 3875167 · Received June 16, 2014

    Report

    Report Number
    3008973940-2014-00230
    Event Type
    Death
    Date Received
    June 16, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 21, 2014
    Manufacturer
    MEDTRONIC SINGAPORE OPERATIONS
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE SERIAL NUMBER OF THE LEAD PROVIDED ON THE INITIAL MEDWATCH REPORT WAS INCORRECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY FOLLOWING THE IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM, THE PATIENT DIED. THE PHYSICIAN SUSPECTED CARDIAC TAMPONADE OCCURRED. A VERY SMALL PERICARDIAL EFFUSION WAS CONFIRMED. IT WAS UNDETERMINED IF THE POSSIBLE TAMPONADE WAS DIRECTLY RELATED TO THE DEATH OF THE PATIENT. A CAUSE OF DEATH AND THE TREATMENT GIVEN TO THE PATIENT AT THE TIME OF THE EVENT ARE UNKNOWN. THE PHYSICIAN REPORTED THERE WERE NO ISSUES WITH THE IMPLANTED DEVICE AND LEADS AND THEY DID NOT CAUSE THE DEATH EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352011 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC SINGAPORE OPERATIONS 407452

    Patients

    Seq Age Sex Outcome Treatment
    1 Death A3DR01 IPG, 457445 LEAD