BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE Q-TRAK SUBCUTANEOUS ELECTRODE

    MDR report key: 18188303 · Received November 21, 2023

    Report

    Report Number
    2124215-2023-65989
    Event Type
    Injury
    Date Received
    November 21, 2023
    Date of Event
    April 1, 2023
    Report Date
    November 21, 2023
    Manufacturer
    OSCOR INC
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SHARMA, ESSEIM, ET AL. (2023) - APPROPRIATE INAPPROPRIATE SHOCKS: INAPPROPRIATE OVERSENSING DURING SLOW VENTRICULAR TACHYCARDIA IN A PATIENT WITH A SUBCUTANEOUS IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR - HEART RHYTHM CASE REPORTS 2023;9:222-226 HTTPS://DOI.ORG/10.1016/J.HRCR.2022.12.020

    Description of Event or Problem · 0

    IT WAS REPORTED PER ARTICLE OF INTEREST LITERATURE REVIEW THAT A 50-YEAR-OLD MAN WAS REFERRED FOR VENTRICULAR TACHYCARDIA (VT) ABLATION FOR RECURRENT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SHOCKS. AN SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) WAS IMPLANTED AFTER APPROPRIATE PREIMPLANTATION SCREENING. THE PATIENT DID WELL FOR SEVEN YEARS AFTER HIS INITIAL S-ICD IMPLANTATION, UNTIL HE BEGAN DEVELOPING EPISODES OF SUSTAINED VT REQUIRING APPROPRIATE S-ICD SHOCKS. THESE EPISODES RESULTED IN A LOSS OF CONSCIOUSNESS, AND HE WAS NOT AWARE OF THE RESULTANT SHOCK. OVER THE COURSE OF THE NEXT FIVE MONTHS, HE HAD TWO SIMILAR EPISODES TO THIS DESPITE UP-TITRATION OF BETA-BLOCKER THERAPY, BOTH RESULTING IN ADDITIONAL APPROPRIATE ICD SHOCKS. THE PATIENT OPTED TO MOVE FORWARD WITH A VT ABLATION. PRIOR TO THE ABLATION, THE PATIENT'S S-ICD WAS DEACTIVATED. FIVE MONTHS AFTER THE ABLATION, HE AGAIN HAD RECURRENT MONOMORPHIC VT OF SIMILAR MORPHOLOGY AND CYCLE LENGTH TO HIS PRE-ABLATION ARRHYTHMIA, RESULTING IN AN APPROPRIATE SHOCK. HE WAS THEN BROUGHT IN FOR A REPEAT VT ABLATION, THIS TIME WITH AN ENDOCARDIAL AND EPICARDIAL APPROACH. IN THE RECOVERY AREA, THE PATIENT WAS NOTED TO HAVE FREQUENT RUNS OF SLOW VT AT AROUND 150 BEATS PER MINUTE. HE HAD SYMPTOMS OF PALPITATIONS BUT WAS OTHERWISE HEMODYNAMICALLY STABLE AND AWAKE DURING THESE EPISODES. HOWEVER, HIS DEVICE WOULD DELIVER DEFIBRILLATION THERAPY FOR THESE EPISODES DESPITE BEING BELOW THE CONDITIONAL SHOCK ZONE. HIS DEVICE WAS DEACTIVATED WITH A MAGNET, AND INTERROGATION OF HIS DEVICE REVEALED DOUBLE-COUNTING OF THE QRS DURING THE VT, RESULTING IN THESE INAPPROPRIATE SHOCKS. HIS S-ICD WAS THEN EXTRACTED AND REPLACED WITH A SINGLE-CHAMBER TRANSVENOUS ICD. TWO MONTHS AFTER IMPLANTATION OF A TRANSVENOUS ICD, HE HAD RECURRENCE OF A FASTER VT, WHICH WAS SUCCESSFULLY TERMINATED WITH ANTI-TACHYCARDIA PACING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722820 THE Q-TRAK SUBCUTANEOUS ELECTRODE IMPLANTABLE LEAD LWS OSCOR INC

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention| H