BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCOR MODEL 111-256

    MDR report key: 163691 · Received April 17, 1998

    Report

    Report Number
    MW1013563
    Event Type
    Injury
    Date Received
    April 17, 1998
    Date of Event
    November 29, 1997
    Report Date
    April 14, 1998
    Manufacturer
    VASCOR MEDICAL
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 2/18/97 VASCOR MODEL 111-246 VENTRICULAR LEAD WAS IMPLANTED. INITIAL EVALUATION POST-OP WAS PERFORMED ON 2/26/97 WITH SUBSEQUENT TESTING DONE ON 4/2/97, 5/21/97 & 9/3/97. THRESHOLDS WERE EXCELLENT DURING PACEMAKER EVALUATIONS AND THE BIPOLAR RESISTANCE RANGED FROM AN INITIAL 609 OHMS ON 2/26/97 TO 714 OHMS ON 4/2/97, 744 OHMS ON 5/21/97, AND 800-892 OHMS ON 9/3/97. SHE SUBSEQUENTLY DEVELOPED MULTIPLE SYNCOPAL EVENTS AROUND 11/29/97 AND PRESENTED TO THE EMERGENCY ROOM ON 12/4/97 DUE TO PERSISTENT PROLONGED SYNCOPE. EVALUATION OF HER PACEMAKER DISPLAYED INTERMITTENT OVERSENSING AND INHIBITION WITH UNDERLYING VENTRICULAR ASYSTOLE. THE VENTRICULAR LEAD WAS URGENTLY REPLACED IN SURGERY ON 12/4/97.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R