BEUDAMED
    FDA Adverse Event Other Summary report: N

    MYOCARDIAL SUTURELESS PERMANENT PACING LEAD

    MDR report key: 142282 · Received January 7, 1998

    Report

    Report Number
    2182269-1998-00001
    Event Type
    Other
    Date Received
    January 7, 1998
    Date of Event
    November 26, 1997
    Report Date
    January 7, 1998
    Manufacturer
    DAIG CORP.
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    EVENT REPORTED BELOW AS DESCRIBED IN MEDWATCH REPORT RECEIVED FROM USER FACILITY: PT W/HISTORY OF ICD IMPLANT IN 1994 PRESENTED ON 11/25/1997 FOR ICD CHECK. MD DOCUMENTS FOLLOWING CLOSELY DUE TO END OF LIFE. INTERROGATION OF DEVICE REVEALED CHARGE SUM GREATER THAN 25 SECONDS. ON 11/25/1997, SHE UNDERWENT EVALUATION OF DEFIBRILLATOR. A FRACTURE OF ONE OF THE PACING LEADS WAS FOUND. THE OLD DEVICE WAS EXPLANTED, LEADS WERE CAPPED AND THE ABOMINAL POCKET WAS CLOSED. A NEW DEVICE WAS IMPLANTED. THERE WERE NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYOCARDIAL SUTURELESS PERMANENT PACING LEAD Implant PACING LEAD DTB DAIG CORP. ML-151 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other