The correction relates to the implantable pulse generator (IPG) battery elective replacement indicator (ERI) for patients implanted with the non-rechargeable Infinity deep-brain stimulation (DBS) neurostimulation systems.
According to Abbott, the duration between the IPG reaching ERI threshold and end of service (EOS) may land 45%-55% shorter than indicated in the product labeling. EOS refers to IPG battery reaching the end of life. Abbott says the shorter duration occurs due to the IPG reaching ERI threshold later than expected. It does not involve premature IPG battery depletion and it does not impact estimates of overall battery life.
Abbott says that, to date, it received no reports of permanent harm to patients resulting from the issue. From February 2017 to April 2024, the company received four complaints in total. It said the four complaints came out of more than 10,500 devices that reached EOS.
The issue could result in loss of therapy if the device reaches EOS prior to replacement surgery. In each of the reported events, the patient lost therapy, but it was restored after replacement surgery. Risks to health could include a recurrence of movement disorder symptoms or (in rare cases) DBS withdrawal syndrome, requiring acute medical intervention. In these rare cases, this could lead to permanent impairment or death, Abbott said.
Abbott says it has work underway to provide an update to align the product labeling with the actual device performance.
Additional information from Abbott
Abbott also issued a notice warning physicians that the same ERI issue for the IPG battery may occur with non-rechargeable Proclaim neurostimulation systems, which also may have a 45%-55% shorter threshold for the duration between the IPG reaching ERI threshold and EOS.
To date, Abbott reports zero cases of permanent harm resulting from the issue. From February 2017 through April 2024, Abbott received two complaints from the more than 27,766 Proclaim devices that reached EOS. In each event, the patient lost therapy before it was restored after replacement surgery.
A company spokesperson shared the following statement with MassDevice via email:
“Abbott has received a very small number of complaints regarding an issue with the implantable pulse generator (IPG) battery elective replacement indicator (ERI) for patients with Abbott’s non-rechargeable neurostimulation systems, including Proclaim SCS, Proclaim DRG, and Infinity DBS Neurostimulation Systems. The ERI notification appears later than expected and therefore the duration between ERI notification and end of service may be shorter-than-expected. In very few instances, this issue caused patients to lose therapy. However, therapy was restored after a planned replacement surgery. Importantly, there have been no reports of permanent patient harm and no products need to be returned to the company or replaced ahead of their ERI date.”
This story was updated a day later with additional information shared by Abbott.
