BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC

    MDR report key: 514858 · Received March 4, 2004

    Report

    Report Number
    514858
    Event Type
    Death
    Date Received
    March 4, 2004
    Date of Event
    February 6, 2004
    Report Date
    February 25, 2004
    Manufacturer
    MEDTRONIC
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 6/30/04: NO ADDITIONAL INFO WAS RECEIVED ON THE EVENT THEREFORE A PRIMARY AND SECONDARY CAUSE OF DEATH IS UNK. THROUGH ROUTINE FOLLOW-UP MEDTRONIC HAS REQUESTED THIS INFO FROM THE HEALTH CARE PROVIDER. TO DATE, NO ADDITIONAL INFO HAS BEEN RECEIVED. THE EVENT DESCRIPTION (B5 OF THE REFERENCED MEDWATCH REPORT) SUGGESTS THE DEATH WAS NOT DEVICE RELATED (STATED AS "NOT DUE TO THE PALER [PACER] LEAD"). THE DEVICE WAS NOT RECEIVED FOR ANALYSIS; THEREFORE, A CAUSAL RELATIONSHIP OF 'NO CONCLUSION CAN BE DRAWN' IS APPROPRIATE.

    Description of Event or Problem · 1

    PT HAVING LASER REMOVAL. DURING LASING OF 2ND LEAD, PT PRESSURE DROPPED. HR DECREASED. INITIATED CPR - ECHO CONFIRMED. PERICARDIOCENTESIS DONE. PT EXPIRED. NOT DUE TO THE PACER LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC PACEMAKER LEADS DTB MEDTRONIC 6957J VIEW 4011

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| H