Boston Scientific has issued a hazard alert in Australia about its SQ-RX Model 1010 Pulse Generator in some of the first-generation subcutaneous implantable cardioverter defibrillator (S-ICD) systems.
The alert was issued by the company in consultation with Australia Therapeutic Goods Administration (TGA).
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S-ICDs are implantable devices that deliver small electrical impulses to address abnormal heart rhythms.
The medical device company found a shortened replacement interval following a battery depleted (BD) alert or when the battery status is elective replacement indicator (ERI).
TGA said that latent S-ICD battery malfunctions can cause rapid battery depletion and need to be replaced earlier.
Boston Scientific has already alerted cardiologists and surgeons who implanted S-ICDs containing a SQ-RX Model 1010 Pulse Generator. The company has advised that patients experiencing unexpected symptoms or hearing beeping from their implanted device should seek medical attention.
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By GlobalDataTGA said: “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.”
Boston Scientific ceased manufacturing the SQ-RX Model 1010 Pulse Generator, and devices with this battery model are no longer implanted.
TGA further noted that the alert does not cover the company’s Emblem MRI or Emblem S-ICD devices, which are embedded with different pulse generators.
Boston Scientific manufactures a variety of medical devices, including those for heart conditions, patient monitoring, retrieval devices and spinal cord stimulator systems.
In the third quarter of this year, the company recorded a 7.7% year-on-year increase in its sales to $2.393bn. Its cardiac rhythm management portfolio generated $475m during the quarter.
