BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2905454 · Received January 9, 2013

    Report

    Report Number
    2124215-2012-13413
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    September 27, 2012
    Report Date
    October 17, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    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

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AT A ROUTINE FOLLOW UP APPOINTMENT, LONGEVITY CALCULATIONS DISPLAYED THREE AND A HALF (3.5) YEARS REMAINING. APPROXIMATELY FIVE MONTHS LATER, LONGEVITY ESTIMATES DISPLAYED ONE (1) YEAR. APPROXIMATELY THREE MONTHS AFTER THAT, LONGEVITY DISPLAYED THREE (3) YEARS. A HEX DOWNLOAD WAS PERFORMED. ANALYSIS CONFIRMED THE DEVICE HAD NO RESETS AND NO MEMORY ERRORS. AT THE TIME OF THE HEX DOWNLOAD, THE DEVICE WAS IN ATRIAL TACHY RESPONSE (ATR) FALLBACK. WHEN THE DEVICE DISPLAYED ONE YEAR OF LONGEVITY REMAINING, THE DEVICE WAS IN RETRY AND HAD AUTOCAPTURE PROGRAMMED ON. THE BATTERY CALCULATOR ESTIMATED THAT THE DEVICE HAS GREATER THAN THREE YEARS OF LONGEVITY REMAINING. IT WAS ALSO NOTED THAT THE DEVICE MAY BE SWITCHING CURRENT BINS DUE TO AUTO CAPTURE GOING INTO RETRY, SETTING THE OUTPUT VOLTAGE HIGHER. THE DEVICE CALCULATIONS SHOWED THE REMAINING LONGEVITY TO BE SLIGHTLY LESS THAN THREE YEARS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT APPROXIMATELY TWO YEARS LATER, UPON INTERROGATION THE DEVICE DISPLAYED A REMAINING LONGEVITY OF ONE YEAR. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS EXPLANTED AND RETURNED FOR RELIABILITY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12928 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR 1388T| MISMATCH| 1346T| 1290