BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURELESS MYOCARDIAL UNIPOLAR LEAD

    MDR report key: 68860 · Received January 9, 1997

    Report

    Report Number
    2124215-1997-00019
    Event Type
    Injury
    Date Received
    January 9, 1997
    Date of Event
    August 1, 1996
    Report Date
    August 1, 1996
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS PATIENT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND A LARGE PATCH LEAD (MODEL 0041, SERIAL 130792), SMALL PATCH LEAD AND TWO UNIPOLAR LEADS (MODEL FOR BOTH, 4312 SERIAL 042086 AND SERIAL 042087) WAS RECEIVING SPURIOUS SHOCKS. THE PHYSICIAN PERFORMED AN INVASIVE PROCEDURE AND DOCUMENTED FRACTURES ON ALL THE LEADS EXCEPT THE SMALL PATCH LEAD. THE LEADS WERE EXPLANTED AND A NEW ENDOTAK LEAD WAS IMPLANTED. IMPLANTED-11/28/90. EXPLANTED-11/28/90. IMPLANT MONTHS-68.1.

    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 64 YR Required Intervention THE DEVICE 1763/800189 WAS IMPLANTED 01-AUG-1996| THE DEVICE 0040/110918 WAS IMPLANTED 28-NOV-1990| THE DEVICE 0041/130792 WAS IMPLANTED 28-NOV-1990| THE DEVICE 4312/042086 WAS IMPLANTED 28-NOV-1990| THE DEVICE 0125/212096 WAS IMPLANTED 01-AUG-1996| THE DEVICE 1600/758401 WAS IMPLANTED 18-MAY-1994