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Health Sciences Authority
Dear Healthcare Professional Letters

Recall of specific lots of StimLoc™ Burr Hole Cover which may have excess nylon flash on the clip due to manufacturing issue

Audiences

Healthcare professional

Industry member

Product type

Medical devices

16 June 2021

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 Ltd to inform healthcare professionals of an urgent recall of specific lots of the StimLoc™ Burr Hole Cover which may have excess nylon flash on the clip due to a manufacturing issue. This issue can prevent the clip from snapping into the StimLoc base, allowing for lead movement or lead damage which could result in therapy delivery to the wrong location, inadequate therapy delivery or intracranial haemorrhage. Healthcare professionals are advised to quarantine and return any unused affected products to Medtronic. No additional patient follow-up is required for previous lead placements with the affected lots where assembly and fixation with the StimLoc base, clip, and cap were successful. Healthcare professionals are also reminded to avoid significant contact between the lead body and the support clip during any lead placement procedure to prevent changing the lead position, and to ensure that the lead body is positioned in the base exit slot before installing the cap to prevent damage to the lead. If there is any difficulty with anchoring the lead with kit components at any time during an implant procedure, a new lead and StimLoc™ Burr Hole Cover assembly should be used. 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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