Are manufacturers of ICDs and CRTs at risk for major product recalls due to Premature Battery Depletion?
Report Available: March 15, 2017
Blueshift’s initial research, in conjunction with Pharm3r software solutions, reveals a pattern of Premature Battery Depletion for several ICD and CRT devices that is consistent with other ICDs and CRTs that have previously been recalled. PBD can cause serious adverse events and death in patients implanted with these devices. Manufacturers and their patients with non-recalled devices that are exhibiting the same PBD patterns as recalled devices could be at a very high risk.
- On Oct. 10, 2016, the FDA issued a Class 1 recall of STJ’s Fortify, Unify, and Assura ICDs and CRT-Ds. The recall was required because certain models were reported to experience rapid battery failure caused by deposits of lithium, known as lithium clusters. Patients with implanted devices of this type are at risk of death if they are unaware of the battery depletion and are in need of its life-saving shock or pacing.
- Two deaths have been linked to the STJ ICD/CRT because a depleted battery could not provide needed shock therapy. Ten patients have fainted because the battery-drained devices did not provide needed pacing therapy, while 37 patients have reported dizziness from the lack of pacing therapy.
- In August 2016, MDT issued an advisory regarding possible rapid battery depletion in some of its devices. Devices in the affected population may experience rapid battery depletion due to a low resistance path developing within a circuit component. In November 2015, MDT recalled its InSync III pacemakers due to power failure problems.
- BSX has experienced battery problems in the past as well. On Aug. 29, 2013, a Class 2 recall was issued for BSX’s Teligen ICD. The performance of a low voltage capacitor may become compromised over time, causing increased current drain that can lead to premature battery depletion.
- Pharm3r’s recent review of publicly available data shows that many non-recalled ICDs/CRTs have high-risk signals that show the same patterns of reported premature battery depletion as recalled products.
How is PBD affecting the use of ICDs and CRTs? Which non-recalled ICD/CRT devices are exhibiting the same patterns of PBD as the St. Jude products? What do cardiologists say about their continued use of these devices? Will their use of these devices change if the PBD trend continues? Which devices/manufacturers will take the place of recalled devices or those with high rates of PBD? Blueshift will issue a market research report by gathering data from independent sources in the following areas: Cardiologists and ICD/CRT specialists, Medical device sales professionals, and Industry specialists.
Companies: Abbott Laboratories (ABT), Boston Scientific Corporation (BSX), LivaNova PLC (LIVN), Medtronic plc. (MDT), St. Jude (STJ)
Research Begins: Feb. 13, 2017