BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCO TIP BI 9/58

    MDR report key: 274230 · Received April 12, 2000

    Report

    Report Number
    2247185-2000-00003
    Event Type
    Injury
    Date Received
    April 12, 2000
    Date of Event
    March 31, 2000
    Report Date
    April 3, 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

    SIGNIFICANT DROP IN BIPOLAR IMPEDANCE. FROM 894-1284 1ST YEAR POST IMPLANT, 922-976 OHMS IN 1998, 741-811 OHMS IN 11/99, 753-826 OHMS IN 12/99 AND ON 3/31/2000 316-327 OHMS BIPOLAR AND 486-491 OHMS UNIPOLAR. THRESHOLDS AND CAPTURE CURRENTLY ACCEPTABLE BUT UNDERSENSING IN BIPOLAR OCCURS AT 2.5MV.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention INTERMEDICS #292-05 (FROM 02/07/1997).