BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCO TIP BI 9/52

    MDR report key: 274259 · Received April 12, 2000

    Report

    Report Number
    2247185-2000-00004
    Event Type
    Injury
    Date Received
    April 12, 2000
    Date of Event
    April 4, 2000
    Report Date
    April 11, 2000
    Manufacturer
    VASCOR 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

    CAPTURE THRESHOLD IN VENTRICLE SHOWED ABRUPT RISE ON 04/04/2000. INTERMITTENT LOSS OF CAPTURE @ 5.4V @ 0.5 MSEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCO TIP BI 9/52 PERMANENT PACING LEAD DTB VASCOR MEDICAL CORP 111-256/52 *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention 2. OSCOR MEDICAL ZY48PJUSBV (FROM 10/17/1996).| 1. INTERMEDICS 294-03 (FROM 10/17/1996),