FDAnews Device Daily Bulletin
Quality / Medical Devices / Regulatory Affairs / Postmarket Safety

Hong Kong Issues Safety Alert on Sorin Pacemakers

Nov. 22, 2013
A A

The Sorin Group has sent a Dear Doctor letter to physicians after Hong Kong’s Department of Health received eight reports of faulty elective replacement indicators used to program the settings on three of the company’s pacemakers.

The pacemakers in question are Reply models D, DR, VDR and SR, Esprit models D, DR, S and SR and FACIL model DR. According to local supplier Innotronik Hong Kong Limited, which notified the department of the problem, the elective replacement indicators often overestimate the time to replacement, causing the device to be replaced later than expected and potentially resulting in patient death.

Sorin spokeswoman Sophie Delliou said the company has 300,000 implanted pacemakers worldwide and stressed that no serious injuries or deaths have been associated with the errors.  The problem does not affect the pacemakers’ functions or longevity, which tends to be between seven and 12 years, she added.  

The company plans to release a new software upgrade to correct the problem. — Lena Freund

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.