The Department of Health (DH) today (May 6) received notification from St. Jude Medical (Hong Kong) Ltd., a local branch of a multi-national company, about a software problem in its Convert+ Model V-195 Implantable Cardioverter-Defibrillator (ICD).
The model, if programmed by a Merlin PCS programmer running version 7.2.1, version 8.2.1 or version 10.2.0 software, may not deliver therapy under certain circumstances. The defect can be corrected. St Jude Medical recommends doctors who have programmed a patient's device with any of the affected software versions should schedule a follow-up visit to perform the correction recommended by it.
According to St. Jude Medical (Hong Kong) Ltd., one patient has been implanted with this model of ICD in Hong Kong. However, the implanted device has not been programmed with the affected software version. This model of ICD ceased to be sold by the company in Hong Kong since mid-2007.
No patient injury or death has been reported worldwide.
Patients may call St. Jude Medical (Hong Kong) Ltd. at 9682 0488 for further details.
A DH spokesman reminded patients with implanted ICDs that they should seek medical attention immediately if they felt unwell.
Meanwhile, the DH has informed both public and private hospitals, and relevant medical associations of the issue, and will also follow up with St. Jude Medical (Hong Kong) Ltd. on further development, if any.
End/Thursday, May 6, 2010