BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL TR

    MDR report key: 3210011 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07188
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 29, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, RIGHT VENTRICULAR PACING, AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LEAD REVISION OF THIS LEFT VENTRICULAR LEAD TOOK PLACE DUE TO THE PATIENT EXPERIENCING HEART FAILURE SYMPTOMS AND LEFT VENTRICULAR LOSS OF CAPTURE WAS NOTED. THE PACING IMPEDANCES WERE WITHIN NORMAL RANGE THE PAST 21 MONTHS. DURING THE REVISION THE PHYSICIAN NOTED A LOOSE CONNECTION, THE LEAD WAS REMOVED AND THE TERMINAL PIN WAS CLEANED AND TESTED WITH A PACING SYSTEM ANALYZER (PSA). THE LEAD WAS ONCE AGAIN TESTED AND IMPEDANCES HAD DECREASED. THE DEVICE WAS PROGRAMMED TIP TO CAN. PHYSICIAN NOTED THAT PRIOR TO REVISION, PT PRESENTED WITH WIDE COMPLEX QRS WITH RV ONLY PACING. ONCE LEAD WAS REINSERTED AND TIGHTENED DOWN, BIV PACING RESTORED NARROW QRS COMPLEX. IN ADDITION, THE REP NOTED THAT THE PACING THRESHOLDS HAD BEEN HIGH SINCE THE DEVICE CHANGE OUT PROCEDURE, WHICH SUPPORTS THAT A POTENTIAL CONNECTION ISSUE OR BLOOD IN THE TERMINAL PIN WAS PRESENT.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION NOTED THAT THIS DEVICE WAS EXPLANTED DUE TO AN UPGRADE PROCEDURE. AT TIME THE DEVICE HAS NOT BEEN RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311602 CONTAK RENEWAL TR IMPLANTABLE CHF GENERATOR DTB GUIDANT CRM CLONMEL IRELAND H140

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R H140| 4537