Wednesday, May 05, 2010

Software Glitch Found in Medtronic's Latest Defibrillator Line

From 7thSpace:
(Hong Kong) The Department of Health (DH) today (May 5) received notification from Medtronic International Limited (MIL), the local branch of a multi-national medical device manufacturer, that software problems in six of its implantable cardiac devices may risk life-threatening though rare malfunctioning. A DH spokesman said, the affected models are Consulta CRT-D (D234TRK), Secura DR/VR (D234DRG, D234VRC), Maximo II CRT-D (D284TRK) and Maximo II DR/VR (D284DRC, D284VRC).All except Maximo II VR (D284VRC) are distributed in Hong Kong. As of April 19 this year, the manufacturer has received five confirmed reports of defect out of approximately 144 000 devices sold worldwide.However, it is reassuring that no patient injury or death arising from the affected devices has been reported thus far.
I called Medtronic technical support and they confirmed the issue. It appears they are not recommending any additional action on the part of patients be undertaken at this time since the problem is only caused if a rare sequence of events takes place. They are awaiting for FDA approval of a software fix for the problem can be upload during patients' next routine device follow-up to avoid the issue.

More details as they become available...


Addendum 7 May 2010 17:27PM: The Dear Doctor letter from Medtronic, posted today.

1 comment:

Jamie said...

I'm a 22 year old ICD recipient after a Sudden Cardiac Arrest about a year ago, and within the first few weeks of the arrest/surgery I was convinced I woke up because my device (Maximo II D284VRC) was beeping.

My mother, a nurse, and Google, all reassured me this was just a nightmare after the surgery (it was distressing, I was bracing myself for the shock that never came) -- But now, reading this, makes me wonder if I wasn't dreaming..

Something to call my cardiologist tomorrow about anyway!

I'm surprised my doctor didn't tell me about this and a little worried that my software might still be defective!