BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RU PACING LEAD

    MDR report key: 1031648 · Received April 15, 2008

    Report

    Report Number
    1035166-2008-00005
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    January 4, 2008
    Report Date
    April 15, 2008
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER ATTEMPTED TO OBTAIN THE LEAD (FOR ANALYSIS, IF EXPLANTED) AND ANY INFO ASSOCIATED WITH THIS EVENT BY SENDING LETTERS TO THE PHYSICIAN (ON 3/21/2008 AND 3/28/2008). ON 4/2/2008 THE PHYSICIAN'S OFFICE REPLIED STATING THEIR RECORDS SHOW THAT THIS PT HAS NOT HAD AN OFFICE VISIT IN AT LEAST 2 YEARS. THE PHYSICIAN REPLIED AGAIN ON 4/9/2008, STATING THE PT IS NO LONGER BEING FOLLOWED BY THEIR GROUP; HE HAS A DIFFERENT CARDIOLOGIST NOW. ON 4/9/2008 ADDITIONAL RESEARCH FOUND THAT ON THREE MONTHS EARLIER, THE FOLLOWING WAS REPORTED TO THE CUSTOMER: "NO PT SYMPTOMS, SEEING NOISE ON BOTH CHANNELS OCCASIONALLY AS STORED A AND V TACHY EGMS. STRIP #3 EGM SHOWS NOISE (SUSPECT EXTERNAL SINCE ON BOTH CHANNELS AND NO LEAD ISSUE NOTED)". THE PACING SYSTEM REMAINS IMPLANTED, AND AS A RESULT THE CLINICAL OBSERVATION CANNOT BE CONFIRMED. THE EVENT WILL BE RE-EVALUATED SHOULD ADDITIONAL INFO BECOME AVAILABLE. THE DEVICE HISTORY RECORDS AND THE COMPLAINT FILES OF THE LEAD MODEL WERE REVIEWED. NO TREND OF THE SAME OR SIMILAR TYPE WAS FOUND OR INDICATED.

    Description of Event or Problem · 1

    OSCOR WAS NEVER NOTIFIED OF THE FOLLOWING EVENT: IN 2007, THE CUSTOMER WAS NOTIFIED THAT THEIR PACEMAKER HAD STORED VENTRICULAR TACHYCARDIA EPISODES DUE TO POSSIBLE NOISE ON BOTH THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) CHANNELS. THE NOISE OCCURRED ON RANDOM DATES, AND THERE WERE NO ADVERSE PT EFFECTS. IT WAS BELIEVED SOME OF THE NOISE MAY HAVE BEEN EXTERNAL. IN 2008, THE CUSTOMER REPORTED NOISE ON LEAD; THE DEVICE IS ACTIVELY IMPLANTED FOR APPROXIMATELY 14 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RU PACING LEAD PASSIVE FIXATION PACING LEAD DTB OSCOR INC. RU52TJV 1K10

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK RT58 TV