BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUTURELESS MYOCARDIAL UNIPOLAR LEAD

    MDR report key: 120316 · Received September 8, 1997

    Report

    Report Number
    2124215-1997-02129
    Event Type
    Malfunction
    Date Received
    September 8, 1997
    Date of Event
    February 12, 1997
    Report Date
    June 9, 1997
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS UNIPOLAR LEAD WAS CAPPED DUE TO AN INSULATION BREAK. DURING A ROUTINE REPLACEMENT PROCEDURE THE LEAD WAS EXHIBITING INAPPROPRIATE SENSING AND PACING VALUES. A SMALL BREAK IN THE INSULATION WAS FOUND. TWO UNIPOLAR LEADS (BOTH MODEL 4312 SERIAL 021945 AND 021976) ARE INVOLVED IN THE PATIENT'S LEAD SYSTEM, CPI IS UNABLE TO DETERMINE WHICH LEAD HAD THE PROBLEM THEREFORE WILL REPORT ON THE SERIAL 021945 LEAD AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUTURELESS MYOCARDIAL UNIPOLAR LEAD Implant UNIPOLAR LEAD LWS CARDIAC PACEMAKERS 4312 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other THE DEVICE 1625/103577 WAS IMPLANTED 01-MAY-1994| THE DEVICE 0041/103966 WAS IMPLANTED 27-JUN-1988| THE DEVICE 1763/801567 WAS IMPLANTED 12-FEB-1997| THE DEVICE 0125/211988 WAS IMPLANTED 12-FEB-1997| THE DEVICE 0040/102190 WAS IMPLANTED 27-JUN-1988| THE DEVICE 4312/021976 WAS IMPLANTED 27-JUN-1988