Medtronic is committed to providing you with the highest quality products and services and ongoing support.
As part of our commitment, we have created this forum to house important information learned from ongoing use and experience with our products. We believe the content of these product advisories will further patient safety and improve outcomes.
This physician communication provides important safety information related to the potential for lead migration as a result of insert separation within the anchor. The Titan anchor accessory kit is designed for use with Medtronic percutaneous in-line connector spinal cord stimulation leads.
While insert separation within the current Titan anchor is estimated to occur in less than 1% of implants, if it does occur, it may result in lead migration and compromised therapy for the patient including the return of chronic pain.
Read on for detailed information related to this communication.
This Dear Healthcare Professional letter provides information regarding Titan anchor insert separation, along with patient management recommendations. It also informs customers of a modification to the Titan anchor to enhance the bond between the titanium insert and silicone body.
This Dear Healthcare Professional letter enclosure shows the location of the Use By Date on the product packaging within the USA.
A letter that physicians may use to notify patients scheduled to receive a Titan anchor (as part of an initial system implant or revision surgery) of this issue.