BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 17652485 · Received August 30, 2023

    Report

    Report Number
    2124215-2023-46888
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Date of Event
    August 16, 2023
    Report Date
    September 27, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P910073/S043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PRESENTED TO THE HOSPITAL AFTER RECEIPT OF A SHOCK. THE COMPANY REPRESENTATIVE REQUESTED REVIEW OF THE STORED EPISODE BY TECHNICAL SERVICES (TS). TS REVIEWED THE STORED EPISODE AND NOTED HIGH FREQUENCY, LOW AMPLITUDE NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL THAT APPEARED CONSISTENT WITH MYOPOTENTIALS WITH A VENTRICULAR TACHYCARDIA (VT) MARCHING THROUGH AT A RATE OF 210-215 BEATS PER MINUTE (BPM). THE PATIENT WAS NOTED TO HAVE FELT POORLY PRIOR TO RECEIPT OF SHOCK THERAPY. TS DISCUSSED POTENTIAL TROUBLESHOOTING OPTIONS. THE SHOCK THERAPY WAS DEEMED APPROPRIATE; HOWEVER, THE ROOT CAUSE OF THE NOISE WAS NOT DETERMINED. NO CHANGES WERE MADE AND THE PATIENT WAS RELEASED. NO FURTHER ASSISTANCE WAS REQUESTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE. IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PRESENTED TO THE HOSPITAL AFTER RECEIPT OF A SHOCK. THE COMPANY REPRESENTATIVE REQUESTED REVIEW OF THE STORED EPISODE BY TECHNICAL SERVICES (TS). TS REVIEWED THE STORED EPISODE AND NOTED HIGH FREQUENCY, LOW AMPLITUDE NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL THAT APPEARED CONSISTENT WITH MYOPOTENTIALS WITH A VENTRICULAR TACHYCARDIA (VT) MARCHING THROUGH AT A RATE OF 210-215 BEATS PER MINUTE (BPM). THE PATIENT WAS NOTED TO HAVE FELT POORLY PRIOR TO RECEIPT OF SHOCK THERAPY. TS DISCUSSED POTENTIAL TROUBLESHOOTING OPTIONS. THE SHOCK THERAPY WAS DEEMED APPROPRIATE; HOWEVER, THE ROOT CAUSE OF THE NOISE WAS NOT DETERMINED. NO CHANGES WERE MADE AND THE PATIENT WAS RELEASED. NO FURTHER ASSISTANCE WAS REQUESTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE REMAINS IN SERVICE. IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1287663 ENDOTAK RELIANCE G IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 0185 195142

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Unknown