Consumers and health professionals are advised that Boston Scientific, in consultation with the TGA, has issued a hazard alert regarding its SQ-RX Model 1010 Pulse Generator, which is used in certain first-generation Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) systems.
S-ICDs are implantable medical devices that use small electrical impulses to treat abnormal heart rhythms.
It has been identified that there is potential for a shortened replacement interval after a Charge Time (CT)/Battery Depleted (BD) alert or after the battery status reaches Elective Replacement Indicator (ERI). Latent battery malfunctions can lead to accelerated battery depletion and the need to replace it sooner than expected.
Please note, the SQ-RX Model 1010 Pulse Generator is no longer manufactured or implanted. Additionally, this issue does not affect Boston Scientific’s Emblem MRI or Emblem S-ICD devices, as they use different pulse generators and are supported by the Latitude Remote Patient Management System.
Information for consumers
Boston Scientific has written to cardiologists and surgeons who have implanted S-ICDs that use a SQ-RX Model 1010 Pulse Generator, providing further information about this issue.
If you have an S-ICD implanted and experience any unexpected symptoms, or if you hear beeping from your implanted device, seek medical attention.
If you have any questions or concerns regarding this issue, please contact your cardiologist, surgeon or the hospital where the surgery was performed.
Information for health professionals
Patients with an S-ICD that uses a SQ-RX Model 1010 Pulse Generator who are experiencing unexpected symptoms or can hear beeping from their implanted device should be referred to their cardiologist, surgeon or the hospital where the surgery was performed.
Information for cardiologists and suregons
Boston Scientific has written to cardiologists and surgeons who have implanted S-ICDs that use a SQ-RX Model 1010 Pulse Generator, providing further information about this issue including recommendations regarding follow up, evaluating risk and investigating alerts.
If you require this information or have any questions or concerns regarding this issue, please contact Boston Scientific on 02 8063 8299.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.
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