BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA CRT-D

    MDR report key: 4140507 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17452
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 6, 2014
    Report Date
    October 20, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    PMA / PMN Number
    P010012/S255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    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 DEFIBRILLATION, 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. ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT SHOCK IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD WERE GREATER THAN 125 OHMS. TECHNICAL SERVICES WAS CONSULTED AND DISCUSSED TROUBLESHOOTING RECOMMENDATIONS. INFORMATION FROM THE LOCAL AREA SALES REPRESENTATIVE INDICATED THAT FOLLOWING THE RISE IN IMPEDANCE MEASUREMENTS, A DECREASE IN MEASUREMENTS WAS OBSERVED. TECHNICAL SERVICES WAS CONSULTED AND DISCUSSED POSSIBLE PHYSIOLOGIC CHANGE IN THE PATIENT'S BODY. 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 SUBSEQUENT INCREASED SHOCK IMPEDANCE MEASUREMENTS WERE OBSERVED. 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 HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS CONTINUED TO BE OBSERVED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS. THE PHYSICIAN PLANS TO CONTINUE MONITORING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS DEVICE WAS LATER EXPLANTED AND RETURNED WITH NO ADDITIONAL INFORMATION LINKING THE EXPLANT TO THE PREVIOUS REPORTED CLINICAL OBSERVATIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618402 INCEPTA CRT-D IMPLANTABLE DEVICE LWP BOSTON SCIENTIFIC CORPORATION N160 918451

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 4136| 4555| H227| V-193| 1581| 0293| N160