BEUDAMED
    FDA Adverse Event Other Summary report: N

    ST. JUDE MEDICAL PACEMAKER

    MDR report key: 874960 · Received June 15, 2007

    Report

    Report Number
    MW5002892
    Event Type
    Other
    Date Received
    June 15, 2007
    Date of Event
    May 29, 2007
    Report Date
    June 15, 2007
    Manufacturer
    ST. JUDE CLINICAL STUDIES
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADMITTED IN 2007, FROM PERSONAL CARE HOME WITH DIAGNOSIS OF SYNCOPY. HISTORY OF PERMEANT PACEMAKER. ELECTROPHYSIOLOGY DEPARTMENT CONSULTED FOR PACEMAKER INTERROGATION. THE EPS STAFF WAS UNABLE TO CONFIRM THE MODE/TYPE OF PACEMAKER. PATIENT IS A POOR HISTORIAN, NO IDENTIFICATION CARD AVAILABLE, PERSONAL CARE HOME NOTES DID NOT INDICATE PACEMAKER INFORMATION. SINCE EPS STAFF WAS UNABLE TO CONFIRM MODEL/TYPE OF PACEMAKER REQUIRED AS A TRACKABLE DEVICE IMPLANT, THEY PROCEEDED TO CONTACT THE 3 MAJOR VENDORS AS PER THEIR PROTOCOL. THEIR FIRST CONTACT WAS TO ST JUDE MEDICAL WHO INFORMED EPS STAFF THEIR RECORDS INDICATED A ST. JUDE MODEL 2002L WAS IMPLANTED IN 1996. PACER WAS INTERROGATED WITH ST. JUDE EQUIPMENT AND PACER WAS FOUND NOT TO BE FUNCTIONING WITH BATTERY DEPLETION. FIVE DAYS LATER, PATIENT WENT TO THE EPS LAB FOR GENERATOR REPLACEMENT. PATIENT GIVEN LOCAL ANESTHETIC. AFTER THE PHYSICIAN OPENED THE PACEMAKER POCKET 2 INCH INCISION, A MEDTRONIC BIVICD WAS DISCOVERED. MEDTRONIC BIVICD FUNCTION WAS CHECKED AND WAS NORMAL. PACER POCKET WAS CLOSED WITH STERI STRIPS. PROCEDURE WAS TOLERATED WELL WITH NO COMPLICATIONS. ST JUDE DEVICE TRACKING HAD NO RECORD OF THE GENERATOR CHANGE TO MEDTRONIC AT ANOTHER ACUTE CARE FACILITY. CONCERNS: #1. WHEN A PATIENT IS A POOR HISTORIAN THERE IS NO DEFINITIVE WAY WITH 100% CERTAINTY WHAT DEVICE A PATIENT CURRENTLY HAS IMPLANTED. #2. DEVICE TRACKING REQUIRES PAPER FORMS TO BE COMPLETED BY THE FACILITY AND SENT TO THE MANUFACTURER. PAPER PROCESS FOR TRACKING IS CUMBERSOME AND CAN LEAD TO LOST/MISPLACED DOCUMENTS RECOMMENDATION: #1. CONSIDERATION OF A COMPUTERIZED NATIONAL DATA BASE OF IMPLANTED TRACKABLE DEVICES THAT IS HIPPA COMPLIANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL PACEMAKER CARDIAC PACEMAKER DXY ST. JUDE CLINICAL STUDIES 2002L

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other