BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCOR MEDICAL

    MDR report key: 224869 · Received May 25, 1999

    Report

    Report Number
    224869
    Event Type
    Injury
    Date Received
    May 25, 1999
    Date of Event
    May 19, 1999
    Report Date
    May 24, 1999
    Manufacturer
    VASCOR MEDICAL CORP
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    COMPLAINTS OF SIGNIFICANT FATIGUE ALSO OCCASIONAL EPISODES OF FEELING FAINT. HER PACEMAKER LEAD VASCOR WAS WORKING APPROPRIATELY ON ARRIVAL FOR HER PACEMAKER EVAL ON 5/19/1999, THEN SHE SUDDENLY DEMONSTRATED TOTAL NON-CAPTURE IN VENTRICLE. DURING NON-CAPTURE, BIPOLAR LEAD IMPEDENCE MEASURED "LOW OHMS" ON MULTIPLE INTERROGATIONS. ASSESSED IN UNIPOLAR WITH AN IMPEDANCE OF 259-277 OHMS. AT IMPLANT RESISTANCE WAS 820 OHMS. AT 1ST POST-OP VISIT 1/29/1997 BIPOLAR RESISTANCE WAS 698 OHMS. ON 3/12/1997 BIPOLAR OHMS WAS 901 OHMS AND RANGED FROM 862-1030 OHMS THROUGH 6/17/1998, 9/16/1998 WAS 839-873 OHMS, 12/16/1998 WAS 717-735 OHMS, 2/1/1999 WAS 647-654 OHMS. CAPTURE AND SENSING THRESHOLDS WERE CONSISTENTLY FAIR THROUGHOUT F/U AT APPROX 2.5 VOLTS AT 0.6 MSEC AND 5-6 MV SENSING THRESHOLD. ON 5/19/1999 LEAD DEMONSTRATED SUDDEN, INTERMITTENT TOTAL NON-CAPTURE, BIPOLAR & UNIPOLAR OVERSENSING. IMPLANTING PHYSICIAN IS 7TH IMPLANTING PHYSICIAN TO HAVE SUDDEN FAILURE OF THIS MODEL VASCOR LEAD IN FOLLOW-UP CLINIC ALONE. PT WILL BE GOING TO ANOTHER CLINIC FOR LEAD REPLACEMENT & VASCOR LEAD, IF REMOVED, WILL BE SENT FOR INDEPENDENT ANALYSIS. FORTUNATELY, FOR THIS PT SHE HAD AN UNDERLYING SINUS BRADYCARDIA AT 40 SO THE FAILED VASCOR LEAD DID NOT RESULT IN HER DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCOR MEDICAL Implant VENTRICULAR PACEMAKER LEAD DTB VASCOR MEDICAL CORP 111-256 *

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R