China's State Drug Administration (SDA) Tuesday issued an urgent notification of a nationwide investigation of cardiac pacemakers produced by the US-based St. Jude Medical, Inc.
The notification says that related reports reveal that incompetent joint welding for the "Tempo" implantation pacemakers may incur early exhaustion of the batteries and lower their reliability.
The notification lists the models of pacemakers that need to be investigated, which include "VR1102," "V1902", "DR2102" and "D2902", with their product serial numbers ranging from OU6100663 to OU6227334.
The "Tempo" pacemakers have to be embedded in the human body for long periods, and may pose a serious threat to people's health if they have quality problems or are improperly used, according to the notification.
The notification urges the medical administration organs and medical services at all levels in China to conduct a systematic and detailed investigation of the pacemakers now in use, demanding that no more of the "Tempo" pacemakers listed above be used.
( December 12, 2001)
