BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2042395 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01823
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 18, 2011
    Report Date
    July 22, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT WHILE THE PATIENT WAS IN THE HOSPITAL FOR AN UNRELATED HEALTH ISSUE, SHE EXPERIENCED SYNCOPE. THE ELECTROGRAM SHOWED THAT THE NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING OF ATRIAL TACHYCARDIA RESPONSE EPISODES AND LOW P-WAVE AMPLITUDE. THE ELECTROGRAM ALSO SHOWED THAT THE NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW R-WAVE AMPLITUDE AND INTERMITTENT CAPTURE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED THE ELECTROGRAM STRIPS AND NOTED THAT THE PATIENT WAS EXPERIENCING TRUE VENTRICULAR TACHYCARDIA (VT) EPISODES AROUND THE SAME TIME AS THE SYNCOPE OCCURRED. HOWEVER, TS WAS UNABLE TO COMPLETE RULE OUT DEVICE AND THE NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR LEAD INVOLVEMENT. TS DISCUSSED TROUBLESHOOTING AND PROGRAMMING OPTIONS WITH THE SALES REPRESENTATIVE (SR). THE SR WILL CONSULT WITH THE PHYSICIAN IN ORDER TO OPTIMIZE PROGRAMMING FOR THIS PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE PACEMAKER WAS EXPLANTED OVER FOUR YEARS LATER FOR NORMAL BATTERY DEPLETION AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| L S603