BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCO TIP BI 9/52 S

    MDR report key: 226644 · Received June 2, 1999

    Report

    Report Number
    2247184-1999-00007
    Event Type
    Injury
    Date Received
    June 2, 1999
    Date of Event
    May 19, 1999
    Report Date
    May 28, 1999
    Manufacturer
    VASCO MED
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TOTAL NON-CAPTURE IN THE VENTRICLE AND LOW OHMS ON MULTIPLE INTERROGATION IN BIPOLAR. UNIPOLAR IMPEDANCE OF 259-277 OHMS. UNIPOLAR AND BIPOLAR OVERSENSING. OHMS FROM IMPLANT 820; 698; 901; 862-1030; 839-873; 717-735; 647-654.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R INTERMEDICS MODEL #294-03.