The subcutaneous implantable cardioverter defibrillator (S-ICD) is established in the prevention of sudden cardiac death, but recently a defect of the electrode's Sense-B component was reported in some patients. This lead to inadequate shocks due to noise. The cause and incidence of this defect are unknown. The manufacturer issued a warning regarding this defect and a possible premature depletion of the battery in some device. Independent data on the incidence of these issues is limited. Further data is needed to better understand the risk of these complications.
Age range
8 Years
Sex
ALL
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Sense B Electrode Failure
Timeframe: 3 months to 70 months after device insertion