BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POSSIS MYOCARDIAL SUTURELESS LEAD

    MDR report key: 197409 · Received November 14, 1998

    Report

    Report Number
    2183460-1998-00083
    Event Type
    Injury
    Date Received
    November 14, 1998
    Date of Event
    September 16, 1998
    Report Date
    November 11, 1998
    Manufacturer
    POSSIS MEDICAL, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    "CPI" RECEIVED INFO THAT TWO POSSIS LEADS WERE REMOVED FROM SVC. ONE OF THE LEADS HAD AN INSULATION FRACTURE. "CPI" IS UNABLE TO DETERMINE WHICH LEAD HAD THE PROBLEM SO WILL REPORT ON LOT NUMBER 003252.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSSIS MYOCARDIAL SUTURELESS LEAD Implant MYOCARDIAL LEAD LWS POSSIS MEDICAL, INC. 1114 003252

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention