BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELOX P 53 BP

    MDR report key: 517207 · Received January 28, 2004

    Report

    Report Number
    1028232-2004-00013
    Event Type
    Other
    Date Received
    January 28, 2004
    Date of Event
    January 4, 2004
    Report Date
    January 20, 2004
    Manufacturer
    BIOTRONIK GMBH & CO.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT EXPIRED DURING IMPLANT - UNSURE WHY, POSSIBLE PULMONARY EMBOLISM. COULD NOT OBTAIN NORMAL THRESHOLD OR SENSING, DESPITE NORMAL POSITION IN THE RV APEX AND SEPTAL WALL. R-WAVE = 2.5 MV, THRESHOLD = 3.2V, NUMEROUS ATTEMPTS, RESISTANCE = 910 -940 OHMS CONSISTENTLY. PT DEVELOPED HYPOTENSION, THEN ASYSTOLE. COULD NOT REVIVE DESPITE CPR, CODE RED, + E.R. STAFF. LEAD WAS NEVER CONNECTED TO PACER, ONLY PSA. PLEASE CONFIRM THAT THIS LEAD IS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELOX P 53 BP PACEMAKER LEAD DTB BIOTRONIK GMBH & CO. 432 306 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization