BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCO TIP BI 9/58

    MDR report key: 228429 · Received June 16, 1999

    Report

    Report Number
    2247185-1999-00008
    Event Type
    Malfunction
    Date Received
    June 16, 1999
    Date of Event
    May 25, 1999
    Report Date
    June 14, 1999
    Manufacturer
    VASCO MED
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INTERMITTENT OVERSENSING AND NON-CAPTURE. IMPEDANCE 8/14/1997 TO 5/25/1999 RANGE FROM 760-925 OHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCO TIP BI 9/58 Implant PERMANENT PACING LEAD DTB VASCO MED 111-256/58 *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other 1. INTERMEDICS #294-23.