BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2913158 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-16897
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 13, 2012
    Report Date
    February 26, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, DETAILED MECHANICAL AND ELECTRICAL TESTING WAS PERFORMED ON THE DEVICE. THE DEVICE BATTERY STATUS WAS EOL. THE DEVICE FUNCTIONED NORMALLY THROUGHOUT TESTING. LABORATORY ANALYSIS DETERMINED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION; HOWEVER, THE ESTIMATED LONGEVITY REMAINING VALUE APPEARED TO DECREASE MORE QUICKLY THAN EXPECTED BETWEEN ROUTINE FOLLOW-UPS. FACTORS INFLUENCING THE ESTIMATED LONGEVITY REMAINING CALCULATION INCLUDE PACING RATE, AMPLITUDE, PULSE-WIDTH AND LEAD IMPEDANCE. ANY (EVEN SLIGHT) CHANGES IN THESE FACTORS WILL IMPACT THE BATTERY CONSUMPTION CALCULATION AND THEREFORE THE REMAINING LONGEVITY ESTIMATE. PLEASE NOTE THAT, DESPITE THE DROP IN ESTIMATED LONGEVITY REMAINING, THE ACTUAL BATTERY CONDITION DID NOT CHANGE SIGNIFICANTLY BETWEEN FOLLOW-UPS. IN SUMMARY, IT WAS DETERMINED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION, BUT DECLARED EOL EARLIER THAN PREVIOUSLY ESTIMATED. ANALYSIS CONCLUDED THIS DEVICE DID NOT EXPERIENCE A COMPONENT MALFUNCTION OR PREMATURE BATTERY DEPLETION, AND REPLACEMENT INDICATORS WERE DISPLAYED APPROPRIATELY RELATIVE TO THE ACTUAL BATTERY CONDITION. HOWEVER, SERVICE LIFE FELL SLIGHTLY SHORT OF LONGEVITY EXPECTATIONS AS OUTLINED IN THE INSTRUCTIONS FOR USE ORIGINALLY APPROVED FOR AND DISTRIBUTED WITH THIS DEVICE. LONGEVITY ESTIMATION TOOLS HAVE SINCE BEEN REFINED TO BETTER REFLECT ACTUAL DEVICE PERFORMANCE AND CURRENT CLINICAL PRACTICES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP APPOINTMENT, IT WAS NOTED THE DEVICE HAD DECLARED END OF LIFE (EOL). ATTEMPTS TO REPROGRAM THE DEVICE THE VVI WERE UNSUCCESSFUL. THREE MONTHS PRIOR, THE DEVICE HAD A BATTERY STATUS OF GOOD AND THE MAGNET RATE WAS 100 BPM. AS A RESULT, THE DEVICE WAS EXPLANTED. WHEN THE FIELD REPRESENTATIVE RECEIVED THE EXPLANTED DEVICE AND INTERROGATED IT, THE DEVICE INDICATED ELECTIVE REPLACEMENT NEAR (ERN) FOUR DAYS AFTER THE LAST FOLLOW-UP. AFTER SOME INVESTIGATION, IT WAS REVEALED THAT THE OUTPUT HAD BEEN INCREASED DURING THE MOST RECENT FOLLOW-UP. WHEN THE FIELD REPRESENTATIVE ATTEMPTED TO PROGRAM THE DEVICE TO VVI, A MESSAGE ABOUT ATRIAL TACHY RESPONSE (ATR) PACING MODE CAME UP. THEREFORE, THE MODE SWITCH WAS REPROGRAMMED TO DDI AND THEN THE DEVICE COULD BE PROGRAMMED TO VVI. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19649 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 0986

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R