BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDRIL SDX

    MDR report key: 1050425 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01406
    Event Type
    Death
    Date Received
    May 27, 2008
    Date of Event
    March 2, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER. NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST IMPLANT, THE PATIENT WENT INTO CARDIAC TAMPONADE. THE PHYSICIAN PERFORMED A PERI- CARDIOCENTESIS, HOWEVER, THE PATIENT EXPIRED OVERNIGHT. THE PHYSICIAN REPORTED, THAT A PERFORATION HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1688T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death