BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 4232353 · Received November 6, 2014

    Report

    Report Number
    2124215-2014-19591
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    March 1, 2013
    Report Date
    April 8, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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. 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE AND ASSOCIATED RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD DISPLAYED NOISE AND OVERSENSING. THE NOISE WAS NOT ABLE TO BE REPRODUCED WITH ISOMETRICS AND IMPEDANCES WERE SAMPLED WITHOUT CHANGE. THE DEVICE WAS PROGRAMMED TO STORE ATRIAL TACHYCARDIA EVENTS AND REPROGRAMMED TO AAI. OF NOTE, THE PATIENT WAS REPORTED TO HAVE HAD A SYNCOPAL EPISODE APPROXIMATELY A YEAR AND A HALF AGO. AT THAT TIME OF THE PATIENT'S SYNCOPE THE DEVICE HAD BEEN PROGRAMMED AAI. THE DEVICE WAS REPROGRAMMED TO DDD. THERE WAS NO EVIDENCE OF A DEVICE PERFORMANCE ISSUE THAT WAS SUSPECTED TO HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S SYNCOPE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE SYSTEM REMAINS IN SERVICE.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATED THAT THE PATIENT UNDERWENT A DEVICE UPGRADE PROCEDURE. THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714585 ALTRUA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR S603| 4136