Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its Stimloc Burr Hole Cover [Part Numbers 3387S-40, 3389S-28, 3389S-40, 3391S-40, 3550S-01, 924256, DB-5000; Lot number: multiple; please refer to the customer letter of the recall].
The manufacturer is recalling specific lots of the Stimloc Burr Hole Cover due to a manufacturing issue resulting in excess nylon flash on the clip. This issue can prevent the clip from snapping into the Stimloc base, which could allow for lead movement or lead damage. This could potentially result in delivery of therapy to the wrong location, inadequate delivery of therapy, or intracranial haemorrhage.
According to the manufacturer, if it was able to complete placement, position the lead in the base exit slot, and snap the cap onto the base; the lead would be properly secured as described in the Instructions for Use (IFU). Previous lead placements with the affected lots where there was successful assembly and fixation with the Stimloc base, clip, and cap do not require additional patient follow-up.
Affected users should identify, segregate, and quarantine unused affected units within their inventory. Product recall is on-going.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 9 Jun 2021