BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POSSIS SUTURELESS MYOCARDIAL LEAD

    MDR report key: 39696 · Received September 20, 1996

    Report

    Report Number
    2124215-1996-09004
    Event Type
    Injury
    Date Received
    September 20, 1996
    Date of Event
    July 23, 1996
    Report Date
    August 22, 1996
    Manufacturer
    POSSIS MEDICAL, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN INVASIVE PROCEDURE WAS PERFORMED TO REMOVE TWO RATE SENSING LEADS, A LEAD (MODEL 4328 SERIAL 000510) AND A BIPOLAR LEAD (MODEL 4266 SERIAL 007701) BECAUSE OF INAPPROPRIATE SHOCKS AND AN ABNORMAL BEEP-O-GRAM. THE PHYSICIAN ELECTED TO REPLACE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND ALL THE LEADS. DISTRIBUTOR UNABLE TO CONFIRM THE MODEL SERIAL NUMBER OF THE RATE SENSING LEAD AT THIS TIME, BOTH LEADS ARE LISTED ON THIS REPORT. CO'S LEAD IMPLANTED 10/28/91. REMOVED FROM SERVICE 7/23/96. IMPLANT MONTHS-57. BIPOLAR LEAD IMPLANTED 12/16/94. REMOVED FROM SERVICE 7/23/96. IMPLANT MONTHS -19.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSSIS SUTURELESS MYOCARDIAL LEAD Implant LEAD LWS POSSIS MEDICAL, INC. 4320 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention MODEL # 0041. SERIAL # 141665| MODEL # 0041. SERIAL # 141666| MODEL # 4266. SERIAL # 007701| MODEL # 1740. SERIAL # 102130| MODEL # 0125. SERIAL #201395| MODEL # 1600. SERIAL # 759843