BEUDAMED
    FDA Adverse Event Injury Summary report: N

    200902-ECG PLUS/SAT LT/EMC

    MDR report key: 477982 · Received August 15, 2003

    Report

    Report Number
    1222791-2003-00010
    Event Type
    Injury
    Date Received
    August 15, 2003
    Report Date
    August 15, 2003
    Manufacturer
    0700-C.R.BARD ELECTROPHYSIOLOGY PRODUCT/GLENS FALLS MANUFACTURING OPERATIONS
    Product Code
    DRQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT HAD AN ABLATION DONE WITH A LABSYSTEM AND A CARTO SYSTEM. AFTER THE PROCEDURE THE PT HAD A BURN ON THEIR RIGHT LEG WHERE THE RL PATCH AND LEAD WIRE WERE. ACCOUNT STATED THAT IT WAS NOT A REACTION TO THE PATCH. THE BURN NECROSED THE TISSUE WITH A 1/2 LESION AND WILL BE HAVING PLASTIC SURGERY ON THE SPOT. THE PT IS IN STABLE CONDITION AND THE STAMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 200902-ECG PLUS/SAT LT/EMC 126010065-LABSYSTEMS DRQ 0700-C.R.BARD ELECTROPHYSIOLOGY PRODUCT/GLENS FALLS MANUFACTURING OPERATIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention