Safety Advisories Notice: Medtronic Reveal LINQ with TruRhythm (LNQ11) and LINQ II (LNQ22)
June 22, 2021 - Medtronic has announced a medical device correction for the LINQ and LINQ II insertable cardiac monitors (ICMs).
Reveal LINQ with TruRhythm
Publication Date: June 21, 2021
The Reveal LINQ with TruRhythm is designed to undergo a partial electrical reset if the device detects a possible issue with its software. An error in the partial reset implementation is resulting in the inability to detect and to report any brady or pause events even when the device is programmed ON to store these episodes. Brady and pause events will not be reported after the reset occurs.
Medtronic estimates that this has occurred in 0.049% of Reveal LINQ with TruRhythm devices to date. The incidence is projected to be 0.056% at 36 months. Based on review of reported events and complaints, it is believed that the majority of the partial electrical resets have been due to EMI from cardioversion or electrocautery. Tachy and AT/AF events are not affected, and the Patient Activator will continue to manually store patient triggered events.
For implanted devices, a software update to correct this issue is anticipated to be available by the end of this year. This update will require an in-person interrogation with a programmer.
The Reveal LINQ with TruRhythm continues to be available for implant and an update to the manufacturing of these devices is anticipated to be in place around October 2021.
LINQ II (LNQ22)
The LINQ II is designed to undergo a partial electrical reset if the device detects a possible issue with its software and the reset implementation can result in the inability to detect and to report any brady, pause, or PVC events even when the device is programmed ON to store these episodes. Medtronic estimates that 0.21% of LINQ II devices have undergone a partial electrical reset. The incidence is projected to be 0.73% at 36 months.
Unlike the Reveal LINQ with TruRhythm, the LINQ II monitors should be removed from hospital inventory and any unused LINQ II monitors should be returned to Medtronic. There is no software update that will become available for implanted LINQ II devices; An update to the manufacturing of these devices to correct this issue has been FDA cleared. Newly available devices will be available in the United States later this month, in June, 2021; Medtronic will be providing guidance to distinguish between the updated devices and those that remain susceptible to the issue.
Recommendations for both Reveal LINQ with TruRhythm (LNQ11) and LINQ II (LNQ22)
Medtronic has sent a letter notifying clinicians if any of their patients transmitting on CareLink have a device that underwent a partial electrical reset. Going forward, if a partial electrical reset occurs, there will be an alert displayed on the programmer or CareLink report (Once the message is cleared it will no longer be viewable).
If an electrical reset has not occurred, continue following the patient remotely with CareLink.
If the programmer or Carelink display a message that a reset has occurred, contact Medtronic technical services.
Review the Brady lifetime episode counter from CareLink. If this is not available, consider an in-person interrogation. If the brady count is not zero, an electrical reset has not occurred. If it is zero, a reset may have occurred, and Medtronic technical services should be contacted (RS.LINQElectricalResetFCA@medtronic.com or in the U.S. call 1-800-929-4043).
Routine device replacement is not recommended; however, in select patients who have had a partial electrical reset and are being monitored for brady events, and are unable to use the patient activator, device replacement should be considered.
Adverse reactions or quality problems experienced with the use either of these products should be reported to Medtronic or to the FDA MedWatch Safety Information and Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit a report online at www.fda.gov/medwatch/report.htm.
- Call 1-800-332-1088 to request a reporting form or download from www.fda.gov/MedWatch/getforms.htm. Forms may be mailed or faxed. Follow instructions on form.