BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 3212553 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09839
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 21, 2013
    Report Date
    October 8, 2013
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. VISUAL INSPECTION CONFIRMED THE HEADER WAS LOOSE FROM THE DEVICE CASE. LOOSE/SEPARATED HEADERS ARE DUE TO AN INSUFFICIENT BOND STRENGTH BETWEEN THE HEADER AND THE DEVICE CASE. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. LABORATORY ANALYSIS WAS NOT ABLE TO CONFIRM THAT THE DEVICE REVERTED FROM END OF LIFE BATTERY STATUS BACK TO ELECTIVE REPLACEMENT TIME BATTERY STATUS; A REVIEW OF DEVICE MEMORY VERIFIED THE END OF LIFE INDICATORS FUNCTIONED AS DESIGNED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER WAS EXPLANTED AND REPLACED FOR NORMAL BATTERY DEPLETION. IT WAS NOTED THE DEVICE WAS AT ELECTIVE REPLACEMENT TIME (ERT) BATTERY STATUS AT THE PREVIOUS DEVICE CHECK ON (B)(6) 2013; HOWEVER, THE BATTERY STATUS PRINT OUT SHOWED END OF LIFE (EOL) WAS DECLARED (B)(6) 2013. THE PHYSICIAN OPENED THE POCKET AND REMOVED THE DEVICE. AT THAT TIME, THE PHYSICIAN OBSERVED THE HEADER HAD ALMOST COMPLETELY BROKEN AWAY FROM THE DEVICE. THE FIELD REPRESENTATIVE CONFIRMED IT APPEARED THE DEVICE AND HEADER WERE CONNECTED ON ONLY ONE SIDE. A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. DURING THE PROCEDURE, THE CHRONIC RIGHT ATRIAL (RA) LEAD WAS SURGICALLY ABANDONED DUE TO THE PATIENT'S ATRIAL FIBRILLATION, AND THE CHRONIC RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED DUE TO HIGH PACING THRESHOLD MEASUREMENTS. THERE HAD BEEN NO DEVICE ISSUES REPORTED WHILE THE DEVICE WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313901 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CLONMEL IRELAND 1297

    Patients

    Seq Age Sex Outcome Treatment
    1