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The Department of Health (DH) has drawn public attention to a field safety advisory relayed by the UK Medicines and Healthcare Products Regulatory Agency concerning possible premature battery depletion in a number of SQ-RX pulse generators by Cameron Health. The pulse generators are a component of the Cameron Health S-ICD System, which is an implantable cardioverter-defibrillator prescribed for patients when cardiac arrhythmia management is warranted.
According to the advisory, spotted via DH's regular surveillance, medical device manufacturer Cameron Health, Inc. determined that a specific subset of SQ-RX pulse generators, model number 1010, may not achieve the five-year typical longevity due to premature battery depletion.
Premature battery depletion under this condition may also result in the time between the onset of the Elective Replacement Indicators (ERI) and End of Life (EOL) indicators to be less than the nominal three months. Therapy remains available through the onset of ERI, but may not be available throughout the period between ERI and EOL.
Cameron Health has confirmed one occurrence of a device experiencing premature battery depletion as described above but no patient injury or death related to this condition has been reported.
While DH is following up with the manufacturer on the supply of the device in Hong Kong, a spokesman urges patients who might have the affected device implanted to contact their physicians immediately should they notice an audible tone emitted from the device or should they have any queries.
The department has alerted the Hospital Authority, private hospitals, relevant institutions and medical associations to the field safety notice.
While DH has not received any adverse report so far, the department will maintain vigilance and monitor the development of the issue.
Ends/Tuesday, June 7, 2011
Issued at HKT 20:30
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