BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2162597 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-08072
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 20, 2011
    Report Date
    July 28, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 HEADER WAS EXAMINED UNDER HIGH POWER MICROSCOPE AND SEAL PLUGS AND ADHESIVE APPEARED NORMAL AND THE SEAL APPEARED INTACT. 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. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. ANALYSIS COULD NOT CONFIRM A REASON FOR THE REPORTED CLINICAL ALLEGATION AND CONCLUDED THE DEVICE MET SPECIFICATION.

    Additional Manufacturer Narrative · 1

    WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS PACEMAKER AND RIGHT VENTRICULAR LEAD PRESENTED TO THE EMERGENCY ROOM. INTERROGATION REVEALED INTERMITTENT RIGHT VENTRICULAR LOSS OF CAPTURE OCCURING EVERY OTHER BEAT. THE PATIENT REPORTED SYMPTOMS OF DIZZINESS, HOWEVER IS HEMODYNAMICALLY STABLE. THIS DEVICE HAS BEEN IMPLANTED APPROXIMATELY EIGHT YEARS AND IS INCLUDED IN THE CRYSTAL TIMING COMPONENT FAILURE MODE 2 PRODUCT ADVISORY WAS INITIALLY COMMUNICATED ON (B)(6) 2005. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED AND RECOMMENDED DEVICE REPLACEMENT AND VERIFYING RIGHT VENTRICULAR LEAD INTEGRITY. A DECISION REGARDING DEVICE REPLACEMENT PROCEDURE WILL BE PERFORMED IN THE NEAR FUTURE. ADDITIONAL INFORMATION WAS RECEIVED. NO ASYSTOLE GREATER THAN TWO SECONDS WAS REVEALED. IT WAS THOUGHT THIS WAS A LEAD ISSUE DUE TO THE INCREASING IMPEDANCE MEASUREMENTS. THE REVISION PROCEDURE IS SCHEDULED. NO FURTHER PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Other 4457| 4087| 1298