Medtronic (MDT) is notifying physicians about a potential battery problem in a small percentage of its SynchroMed II Implantable Drug Infusion Pumps. The company had initially communicated about reduced battery performance to physicians in July 2009.
However, Medtronic is neither recalling the products from the field nor recommending surgical removal of the device unless a patient’s pump demonstrates reduced battery performance. The company concluded that the formation of a film within the pump battery may impact battery performance. Medtronic has recommended patients to contact their physicians if they experience any problem.
Medtronic is working on a battery design to ensure these types of issues do not occur in future. This change in design has been implemented in several regions including, Europe, Australia, New Zealand, Canada, Africa and India while the company is yet to receive approval in the US. The company recorded 55 cases of pumps with the battery issue out of about 139,653 SynchroMed II pump implants globally. While the pump is designed to last 84 months, these incidents occurred between 45 and 78 months after implant.
Medtronic’s SynchroMed II system is a part of the Neuromodulation segment and delivers small quantities of drug directly into the intrathecal space in the spine. The device is used to treat chronic, intractable pain and severe spasticity associated with cerebral palsy, multiple sclerosis, spinal cord and traumatic brain injuries and stroke.
In the last reported quarter, the Neuromodulation segment generated $432 million in sales, up 5% (4% at CER) from the year-ago period. Medtronic has received CE Mark approval to use its neurostimulator portfolio for peripheral nerve stimulation to treat chronic back pain. While RestoreSensor was launched in Canada and Australia in the quarter, the company is working to introduce the product in the US market. Meanwhile, the product continues to gain traction in Europe. Moreover, the company has received CE Mark approval for Ascenda pump catheter and is aiming at bringing the product to the US in fiscal 2012. Following the FDA approval of InterStim therapy for bowel control, the company is working on securing reimbursement as it plans to expedite its launch in fiscal 2012.
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