The FDA has released a safety communication for patients with a St. Jude Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) device due to batteries failing earlier than expected.
These ICD and CRT-D devices are critical to the survival of patients and there have been 2 reported deaths currently due to battery failure. When a patient receives an ERI alert the battery is expected to have a 3-month lead time before needing replacement. The reports state that the lithium batteries occurred full battery drainage within a day to a few weeks after the patient received an ERI alert.
Device traceability and being able to spread information and warnings to customers is vital for a manufacturer’s success but most importantly the safety and health of their customer.
To view the entire list of devices affected by this issue follow the link below: