BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCO TIP BI 9/56

    MDR report key: 275701 · Received April 25, 2000

    Report

    Report Number
    2247185-2000-00006
    Event Type
    Injury
    Date Received
    April 25, 2000
    Date of Event
    April 14, 2000
    Report Date
    April 18, 2000
    Manufacturer
    VASCOMED MEDICAL CORP
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STEADILY DECLINING IMPEDANCE. BIPOLAR RESISTANCE WAS 943 OHMS ON 12/21/1998 TO 563-579 ON 04/14/2000. ELECTIVE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCO TIP BI 9/56 PERMANENT PACING LEAD DTB VASCOMED MEDICAL CORP 111-256/56 *

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention INTERMEDICS #294-05(FROM 1997).