BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNAGEN CRT-D

    MDR report key: 12628293 · Received October 13, 2021

    Report

    Report Number
    2124215-2021-26621
    Event Type
    Injury
    Date Received
    October 13, 2021
    Date of Event
    August 19, 2021
    Report Date
    January 6, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIK
    UDI-DI
    00802526534638
    PMA / PMN Number
    P010012/S341
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO H6: PATIENT CODES, IMPACT CODES, DEVICE CODES: PATIENT CODE E0601 REMOVED, IMPACT CODE F23 REMOVED, AND DEVICE CODE A071202 REMOVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS LEFT VENTRICULAR (LV) PACING, VENTRICULAR TACHYCARDIA (VT) WAS INDUCED FOR THIS PATIENT. THE DEVICE WAS REPROGRAMMED TO ELIMINATE LV PACING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT UPON FURTHER REVIEW, LV PACING DID NOT INDUCE VT FOR THIS PATIENT. THE PATIENT HAD PREMATURE VENTRICULAR CONTRACTIONS WHICH LED TO EVENTS REQUIRING ANTI-TACHYCARDIA PACING (ATP). AS PREVIOUSLY REPORTED, THE DEVICE HAD BEEN PROGRAMMED TO RIGHT VENTRICULAR (RV) ONLY PACING, AND IT HAD BEEN QUESTIONED WHY THEY WERE STILL SEEING 100% LV PACING. TECHNICAL SERVICES (TS) EXPLAINED THAT DURING ATRIAL TACHY RESPONSE (ATR) EPISODES THE DEVICE WILL STILL BI-VENTRICULAR PACE. THEY DISCUSSED FURTHER PROGRAMMING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS LEFT VENTRICULAR (LV) PACING, VENTRICULAR TACHYCARDIA (VT) WAS INDUCED FOR THIS PATIENT. THE DEVICE WAS REPROGRAMMED TO ELIMINATE LV PACING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1525797 DYNAGEN CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D NIK BOSTON SCIENTIFIC CORPORATION G151 117520 00802526534638

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention