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Safety alert over certain Medtronic implantable cardioverter-defibrillators

     The Department of Health (DH) today (March 6) received notification from a medical device supplier, Medtronic International Ltd (Medtronic), about its voluntary corrective actions concerning some models of EnTrust and Escudo implantable cardioverter-defibrillators (ICD).

     The ICDs concerned may not meet the expected longevity or provide at least three months of device operation between the Elective Replacement Indicator (ERI) and End of Life (EOL) due to a more-rapid-than-expected drop in battery voltage.

     According to Medtronic, the EnTrust model numbers affected are D153DRG, D153VRC, D153ATG, D154VRC, D154DRG and D154ATG, and Escudo D144DRG and D144VRC. Among the affected models, only EnTrust D154VRC and D154ATG were ever launched in Hong Kong, but they are no longer marketed here now.

     Medtronic has identified the cause of the problem to be an internal battery short that develops as the battery capacity is consumed. So far, no patient deaths or serious injuries have been reported as a result of this issue.

     Medtronic reported that 51 patients in Hong Kong have been implanted with the affected models in both private and public hospitals. The manufacturer is in the process of informing the physicians-in-charge of the patients about the problem and the related management recommendations.

     A DH spokesman advised those patients who have the affected devices implanted should contact their physicians immediately if they feel unwell or have any queries.

     The department has alerted the Hospital Authority, private hospitals, relevant institutions and medical associations to the safety alert.

     While DH has not received any adverse report so far, the department will maintain vigilance and monitor the development of the issue.

Ends/Tuesday, March 6, 2012
Issued at HKT 21:10


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