BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SQ-RX PULSE GENERATOR

    MDR report key: 22312685 · Received June 23, 2025

    Report

    Report Number
    2124215-2025-41528
    Event Type
    Injury
    Date Received
    June 23, 2025
    Date of Event
    April 1, 2010
    Report Date
    June 23, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P110042/S000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    M. F. EL-CHAMI, B. HARBIEH,M. LEVY, A. R. LEON, AND F. M. MERCHANT, CLINICAL AND ELECTROCARDIOGRAPHIC PREDICTORS OF T WAVE OVERSENSING IN PATIENTS WITH SUBCUTANEOUS ICD, JOURNAL OF ARRHYTHMIA 32 (2016): 181-185.

    Description of Event or Problem · 0

    IT WAS REPORTED PER ARTICLE OF INTEREST LITERATURE REVIEW THAT THE AUTHORS SOUGHT IDENTIFY CLINICAL AND ELECTROCARDIOGRAPHIC PREDICTORS OF T-WAVE OVERSENSING (TWOS) IN A COHORT OF PATIENTS UNDERGOING SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD). THEY RETROSPECTIVELY IDENTIFIED ALL PATIENTS WHO UNDERWENT S-ICD IMPLANTATION (CAMERON HEALTH MODEL NUMBER 1010 SQ-RX, WITH A SUBCUTANEOUS LEAD-CAMERON HEALTH MODEL 3010) AT THEIR INSTITUTION FROM APRIL 2010 TO JANUARY 2015. NINETY-TWO PATIENTS UNDERWENT S-ICD IMPLANTATION. DURING A MEAN FOLLOW-UP OF 13.1 MONTHS, SIX PATIENTS HAD TWOS RESULTING IN INAPPROPRIATE SHOCKS. IN THE GROUP WITHOUT TWOS, TWO PATIENTS EXPERIENCED INAPPROPRIATE SHOCKS FOR NON-TWOS ETIOLOGIES: ONE FOR SUPRAVENTRICULAR RHYTHM AND ONE FOR ELECTROMAGNETIC INTERFERENCE. CASE 1: A 34-YEAR-OLD MAN WITH HYPERTROPHIC CARDIOMYOPATHY (HCM) AND SUDDEN CARDIAC DEATH RISK FACTORS UNDERWENT S-ICD IMPLANTATION FOR PRIMARY PREVENTION. HE EXPERIENCED AN INITIAL INAPPROPRIATE SHOCK DUE TO TWOS APPROXIMATELY THREE MONTHS AFTER IMPLANTATION. THE SENSING VECTOR WAS CHANGED FROM PRIMARY TO SECONDARY, AND THE RATE CUT-OFFS FOR DELIVERY OF THERAPY IN BOTH ZONES WERE INCREASED. A WEEK LATER HE PRESENTED WITH ANOTHER INAPPROPRIATE SHOCK FOR TWOS. AN EXERCISE TREADMILL TEST (ETT) WAS PERFORMED WITH ACQUISITION OF A NEW TEMPLATE DURING EXERCISE. HE CURRENTLY HAS HAD NO FURTHER INAPPROPRIATE THERAPIES IN THE 10 MONTHS FOLLOWING THIS, WITH ACTIVITY LIMITATIONS PER GUIDELINES FOR MANAGEMENT OF HCM. THE S-ICD SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1970969 SQ-RX PULSE GENERATOR IMPLANTABLE DEVICE LWS BOSTON SCIENTIFIC CORPORATION 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male Other