Urgent Safety Notice for Dual-Chamber External Temporary Pulse Generator Model 5388, Medtronic
2010.11.04
Product group Medical electronics / Electromedical devices
Reference 03748/10
Medtronic B.V. has issued a Field Safety Notice concerning a corrective action of the dual-chamber external temporary pulse generator Model 5388. A design upgrade resolves a high resistance contact on the electronic circuit board which may result in disabling the device to power up or in powering down the device unexpectedly.