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Health Sciences Authority
Dear Healthcare Professional Letters

Elevated rate of latent battery malfunctions resulting in accelerated battery depletion and shortened replacement interval for Boston Scientific SQ-RX™ Model 1010 Pulse Generator

Audiences

Healthcare professional

Product type

Medical devices

8 November 2018

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

Boston Scientific Asia Pacific would like to inform healthcare professionals of a potential for a shortened replacement interval after a Charge Time (CT) / Battery Depletion (BD) alert has occurred or after the battery status reaches Elective Replacement Indicator (ERI) in the first-generation Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) system’s SQ-RX™ Model 1010 Pulse Generator (PG). It was also observed that there is an elevated rate of these PGs experiencing latent battery malfunctions resulting in accelerated battery depletion and a shortened replacement interval. The projected occurrence rate for latent battery malfunctions for SQ-RX™ Model 1010 PGs is up to 2% at 5 years. The affected medical device is no longer available for implantation as it is no longer manufactured and any remaining inventory has expired. Approximately 9,000 of these devices remain in service. Healthcare professionals are advised to conduct patient follow-ups consistent with the device user manual and consider the increased potential for life-threatening harm in at-risk patients implanted with the affected device. They are also advised to promptly investigate any relevant device alerts and replace the affected device within 20 days of ERI to mitigate the potential for undetected accelerated battery depletion. Please refer to the letter for details.


Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.

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