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Health Sciences Authority
Dear Healthcare Professional Letters

Design update to the Ascenda™ Intrathecal Catheter - Models 8780, 8781 and 8784 (part of the Medtronic Synchromed™ II Programmable Drug Infusion System)

Audiences

Healthcare professional

Industry member

Product type

Medical devices

27 June 2024

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

A Dear Healthcare Professional Letter has been issued by Medtronic International Limited to inform healthcare professionals of a design update to the Ascenda™ Intrathecal catheter models 8780, 8781, and 8784, which are part of the Medtronic Synchromed™ II Programmable Drug Infusion System. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter occlusion. Presence of tissue in the catheter connector may result in a prolonged surgical procedure due to extended troubleshooting (i.e., cleaning and re-attaching the connector or replacing the pump connector). If the presence of tissue in the catheter connector causes an obstruction, it may lead to return of symptoms, loss of therapy and/or life-threatening baclofen withdrawal. Healthcare professionals are advised to ensure that the Ascenda catheter is completely connected to the pump through proper alignment and full engagement of the catheter connector to the catheter port on the pump. Medtronic is not recommending prophylactic replacement of currently implanted Ascenda catheters due to the low observed occurrence rate (0.06%) and the risks associated with replacement surgery. Instead, Medtronic recommends re-emphasising to patients and caregivers the signs and symptoms of withdrawal or return of underlying conditions. 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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