Medtronic’s analysis of the issue indicates that it is related to the formation of a film within the pump battery that reduces battery performance which leads to the sudden loss of therapy and the return of underlying symptoms and/or withdrawal symptoms.
Medtronic said patients receiving intrathecal baclofen therapy are at risk for baclofen withdrawal syndrome, which leads to a life-threatening condition if not treated quickly.
Medtronic encourages patients to carry their patient identification cards with them at all times and to contact their physicians if they experience a return of symptoms or hear a device alarm.
Medtronic is working to obtain US approval for a battery design change intended to prevent the issue from occurring in future pumps.
