Instructions for Use Update
Medtronic Micra™ Delivery System
Packaged as part of Micra™ Transcatheter Pacing System Model: MC1VR01
August 2019
Dear Physician:
Medtronic records indicate you have been trained to implant the Micra Transcatheter Pacing System (TPS). Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during implant.
The functionality of the Micra pacemaker is not affected by this update. No action is needed for patients already implanted with a Micra device, as this update to instructions applies only to new implant procedures.
As of 18-Jul-2019, there have been 52 complaints worldwide involving a tangled tether during tether removal that resulted in prolonged or additional procedures. No deaths have been reported related to this issue.
Medtronic has identified that flushing the delivery system after the tether has been cut may cause the free end of the tether to enter the ventricular chamber and tangle. If this happens, the tangle could potentially prevent tether removal from the delivery system and potentially prevent release of the Micra pacemaker. Therefore, Medtronic is updating the IFU and Implant Procedure Tip Card to include the recommendation below:
- Once the tether is cut, do not flush the delivery system until the tether has been fully removed.
Note, some amount of resistance during tether removal is normal. Tension or resistance during tether removal is not typically indicative of a tangle. If you feel resistance when pulling out the tether, advance the recapture cone closer and/or more coaxially to the device.
Upon regulatory approval, the updated IFU will be available online at http://manuals.medtronic.com/manuals/main.
See Appendix A for an image of the updated section of the Implant Procedure Tip Card in English. The updated Tip Card includes a revision date of August 2019 or later, and can be accessed at http://www.medtronic.com/micratpstipcard, or by contacting your local Medtronic Representative.
Your Actions
- Please implement this new instruction in all future Micra implants.
- Medtronic requests that you complete the provided Confirmation Form and either return it to your Field Representative or email to RS.CFQFCA@medtronic.com, which indicates you received this instruction update.
Medtronic will notify regulatory agencies regarding this communication. FDA may describe this as a recall on their website. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
We are committed to patient safety and appreciate your prompt attention to this matter. Please share this notification with others in your organization as appropriate. If you have questions regarding this material, please contact your Medtronic Field Representative or Technical Services at 800‑505‑4636.
Sincerely,
Chris Harrold
Vice President, Quality and Regulatory
Medtronic Cardiac Rhythm and Heart Failure
APPENDIX A
Section of Micra Implant Procedure Tip Card WITH UPDATE
