BEUDAMED
    FDA Adverse Event Death Summary report: N

    TEMPORARY PACING WIRE

    MDR report key: 90665 · Received May 14, 1997

    Report

    Report Number
    2210968-1997-00126
    Event Type
    Death
    Date Received
    May 14, 1997
    Date of Event
    March 14, 1997
    Report Date
    April 14, 1997
    Manufacturer
    ETHICON, INC.
    Product Code
    GAQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    5/26/97, FOLLOW-UP INFO INDICATES THAT A SERIOUS INJURY OCCURED AND THE DEVICE WAS USED AND NO OTHER SOLE CAUSE OF THE INQUIRY COULD BE IDENTIFIED. A RE-OPERATIVE PROCEDURE WAS PERFORMED. PT EXPIRED 4 WEEKS FOLLOWING A RE-OP FROM MULTIPLE ORGAN FAILURE SECONDARY TO PNEUMONIA CONCURRENT WITH METHICILLIN RESISTANT S AUREUS INFECTION. (REFERENCE: HASEGAWA 5/26/97).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPORARY PACING WIRE Implant NON-ABSORBABLE SUTURE GAQ ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| R OTHER MFR PACING WIRE, MEDTRONIC MODEL 6500