BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 3904243 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09845
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 3, 2014
    Report Date
    January 8, 2018
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD REPRESENTATIVE CONFIRMED THE DEVICE WAS AVAILABLE TO BE RETURNED. THIS REPORT WILL BE UPDATED AFTER THE DEVICE IS RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE REMAINS IN SERVICE. THE PACING OUTPUTS WERE DECREASED TO IMPROVE THE REMAINING LONGEVITY, AND THE PHYSICIAN WILL CONTINUE TO MONITOR THE RATE OF BATTERY DEPLETION. 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

    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. ALL SEAL PLUGS WERE INTACT AND ALL SETSCREWS MOVED FREELY. A REVIEW OF DEVICE MEMORY FOUND RESETS HAD OCCURRED POST-EXPLANT. THE DEVICE WAS EXPLANTED IN FEBRUARY 2017 BUT NOT RETURNED UNTIL DECEMBER 2017. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. GIVEN THE IMPLANT DURATION, THE RESULTS OF THE LONGEVITY CALCULATION INDICATED THAT THE ACTUAL RATE OF BATTERY DEPLETION FELL WITHIN AN ACCEPTABLE RANGE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE FOLLOW-UP, THE REMAINING LONGEVITY FOR THIS PACEMAKER WAS TWO YEARS, AFTER ONLY TWO YEARS OF IMPLANT TIME. THERE WAS CONCERN THE BATTERY WAS DEPLETING PREMATURELY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION. THIS DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO NEW ALLEGATIONS OF PREMATURE BATTERY DEPLETION FROM THE IMPLANTING PHYSICIAN DURING THE REPLACEMENT PROCEDURE. THE PREVIOUS REPORT OF PREMATURE BATTERY DEPLETION HAD COME FROM THE DEVICE FOLLOWING PHYSICIAN, WHO MADE NO NEW COMMENTS ABOUT THE DEVICE LONGEVITY AT THE TIME OF THE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384917 ALTRUA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND S403

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R S403| 5076