PTN No 83 - CPI Guidant : Discovery Models 1174, 1175, 1273, 1274, 1275; Meridian Models 476, 976, 1176, 1276; Pulsar/Pulsar Max Models 470, 870, 970, 972, 1170, 1171, 1172, 1270, 1272

 

May 2000

Further recommendations regarding premature battery depletion.

The Medical Devices Agency (MDA) issued Pacemaker Technical Note 75 in March/April 1999 to pacing centres with regard to premature battery depletion. Centres were advised of specific affected product serial numbers at the time.

MDA and Guidant have been monitoring the efficacy of the 1999 action and MDA have concluded that the action on these products requires updating in the light of further device failures.

Clinicians are advised to:

Identify patients implanted with pacemakers from the notified affected serial numbers (serial numbers as advised by Guidant in March/April 1999);

Consider monthly follow-up for pacemaker dependent patients to check for early elective replacement indicators (ERT or EOL), until further notice. If monthly follow-up is impractical, consider explantation in pacemaker-dependent patients;

Monitor the battery status in non pacemaker-dependent patients carefully through routine follow up.

MDA and Guidant will continue to review the data on these products and will issue further advice if appropriate.