BIOTRONIK Safety Communication Regarding a Subset of ICDs and CRT-Ds
March 22, 2021 - Earlier this month, BIOTRONIK announced a field safety notice that some ICDs and CRT-Ds are exhibiting premature battery depletion. HRS is working together with BIOTRONIK and the Food and Drug Administration on this communication to ensure our members have the latest, most accurate information.
Publication Date: March 22, 2021
Earlier this month, BIOTRONIK announced a field safety notice that some ICDs and CRT-Ds are exhibiting premature battery depletion. HRS is working together with BIOTRONIK and the Food and Drug Administration on this communication to ensure our members have the latest, most accurate information.>
The premature battery depletion can affect a subset of ICDs and CRT-Ds of the following models;
Idova, Iforia, Ilesto/Inventra, Iperia, Itrevia/ Ilivia, Inlexa, Intica/ Ilivia Neo, and Intica Neo.
The affected devices have been available since 2013, and BIOTRONIK estimates there are 162,000 remaining active devices worldwide, with 38,300 of those in the U.S. Devices affected by the battery depletion typically begin exhibiting lower than expected voltages more than 2 years after implant. The currently observed rate is 0.1%, with a projected depletion rate of 0.17% after 5 years of implant. There have been no deaths or serious adverse events reported due to this issue. The median time between the device triggering ERI and loss of tachyarrhythmia therapy has been 58 days.
Based on analyses of returned devices, lithium plating has been determined to be the root cause. This is where metallic lithium deposits onto the anode of the battery over time. If lithium builds up and "bridges" between the anode and cathode, an internal short will develop and the battery will deplete prematurely.
BIOTRONIK Recommends the Following
- Continue routine follow-up.
- Whenever possible, utilize CardioMessenger Home Monitoring.
- Monitor for unexpected decreases in the battery longevity estimate during follow up.
- Inform a BIOTRONIK representative of any unexpected device behaviors.
- If unexpected ERI is observed, perform prompt device replacement (immediately if pacer-dependent and within 1 week for non-dependent patients).
- BIOTRONIK, in consultation with their Medical Advisory Board, recommends against prophylactic device replacement given the currently observed rate, and the risks associated with device replacement.
HRS strongly encourages its members to read the BIOTRONIK Safety Notice. The serial number lookup page can be used to query potentially affected devices.
Adverse reactions or quality problems experienced with the use of this product should be reported to Biotronik and 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.
For additional questions, contact your local BIOTRONIK Representative or BIOTRONIK Advanced Product Support at 1-800-547-0394 (email@example.com).