BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3771432 · Received April 24, 2014

    Report

    Report Number
    2124215-2014-09099
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 26, 2014
    Report Date
    July 8, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PHYSICIAN

    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

    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 RIGHT VENTRICULAR PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT AN INVASIVE PROCEDURE WAS PERFORMED. NO VISUAL SIGNS OF A FRACTURE OR EVIDENCE OF TWIDDLING WAS OBSERVED AND THE LEAD TO DEVICE HEADER CONNECTION WAS NOTED TO BE SECURE. ADDITIONALLY, A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT GREATER THAN 2,000 OHMS AND LOSS OF CAPTURE (LOC) WAS OBSERVED WHEN THE LEAD WAS CONNECTED TO A PACING SYSTEM ANALYZER (PSA). THE LEAD WAS SURGICALLY ABANDONED AND REPLACED AND THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS PACEMAKER WAS EXPLANTED TO UPGRADE TO A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). THE DEVICE WAS RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE AND OVERSENSING RESULTING IN STORAGE OF TACHYCARDIA EPISODES. ADDITIONALLY, THE DEVICE WAS OBSERVED TO BE PACING IN RETRY DUE TO HIGH THRESHOLD MEASUREMENTS AND LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENTS LESS THAN 200 OHMS WERE OBSERVED RESULTING IN ACTIVATION OF THE LEAD SAFETY SWITCH (LSS) FEATURE. IT WAS NOTED THAT THE PATIENT SUFFERED FROM TWIDDLER¿S SYNDROME. PROGRAMMING CHANGES WERE MADE AND A REVISION PROCEDURE WILL BE CONSIDERED IN THE FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249230 ALTRUA LWP GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 4137| S606