Medical device manufacturer, Biotronik, has issued a medical device safety alert concerning its Idova, Iforia, Ilesto / Inventra, Iperia, Itrevia / Ilivia, Inlexa, Intica / Ilivia Neo, Intica Neo ICDs and CRT-Ds.
The manufacturer has become aware of an increased likelihood of premature battery depletion in a subset of devices of the above-mentioned models of ICDs and CRT-Ds, resulting in an earlier than expected need for device exchange.
According to the manufacturer, analyses of returned devices has revealed the potential for a certain mode of lithium deposition on the anodes of the batteries, known as lithium plating, to occur - lithium plating is a very rare phenomenon that may cause a battery drain at a higher rate than under typical use. The manufacturer states that there is a very low risk that premature battery depletion could result in sudden loss of high-voltage or pacing therapy. However, due to the identified issue, the interval between the elective replacement indicator ("ERI") being triggered and the loss of ability to provide therapy may be shorter than expected. Records showed that for the impacted devices, the median interval from ERI to loss of high voltage therapy was 58 days. The median interval until loss of pacing therapy was 6 months.
Affected users are advised to contact the supplier and follow the patient management recommendations as instructed.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 8 March 2021