BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNAGEN X4 CRT-D

    MDR report key: 8311098 · Received February 6, 2019

    Report

    Report Number
    2124215-2019-02086
    Event Type
    Injury
    Date Received
    February 6, 2019
    Date of Event
    October 29, 2018
    Report Date
    April 18, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    UDI-DI
    00802526534669
    PMA / PMN Number
    P010012/S341
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. HIGH POWER VISUAL INSPECTION OF THE DEVICE HEADER AND SEAL PLUGS NOTED NO ANOMALIES. PIN GAUGE TESTING DESIGNED TO VERIFY PROPER PORT DIMENSIONS WAS COMPLETED, AND EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, WHERE THE PACING AND SENSING FUNCTIONS WERE TESTED. 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. IMPEDANCE TESTING WAS PERFORMED WHERE ALL VALUES WERE WITHIN NORMAL LIMITS. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORT HIGH OUT OF RANGE IMPEDANCES.

    Additional Manufacturer Narrative · 0

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 0

    THE REPORT IS BEING FILED WITH ANALYSIS DETAILS.

    Description of Event or Problem · 0

    THIS SUPPLEMENTAL REPORT IS BEING FILED BECAUSE THE CONCLUSION CODE WAS UPDATED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE HIGH INTERMITTENT SPIKES IN PACING IMPEDANCES ON BOTH LEADS CONTINUED, AND WHEN THE LEAD WAS TESTED IN THE OFFICE AGAIN RECENTLY THEY ARE NOW SEEING OBSERVATIONS OF LOSS OF CAPTURE. PLAN WAS TO HAVE PATIENT SEEN BY THE ELECTROPHYSIOLOGIST. SUBSEQUENTLY, THE DEVICE APPEARS TO HAVE BEEN EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) TRIGGERED AN ALERT ON THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), FOR HIGH OUT OF RANGE PACING IMPEDANCES. IT WAS ALSO DISCOVERED THAT THERE WERE STORED EPISODES OF NOISE OVERSENSING FROM THE RESPIRATORY RATE RESPONSE FEATURE. THE FEATURE WAS TURNED OFF AND SUBSEQUENTLY, THE RIGHT ATRIAL (RA) LEAD PACE IMPEDANCE TRIGGERED AN ALERT FOR OUT OF RANGE PACE IMPEDANCES. BOTH LEADS ARE FROM ANOTHER MANUFACTURER AND IT WAS SUSPECTED THAT THERE WAS A POSSIBLE SPRING CONTACT ISSUE. NO OTHER NOISE EPISODES HAVE BEEN SEEN, SINCE THE PROGRAMMING CHANGE. THE PRODUCT REMAINS IN SERVICE AND THE PATIENT WILL CONTINUE TO BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102146 DYNAGEN X4 CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D NIK BOSTON SCIENTIFIC CORPORATION G156 374179 00802526534669

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R