Alerta De Seguridad para micro-pace™ dual-chamber temporary cardiac pacemaker, ref 4580

Safety alert

2012-07-06

2012-07-06

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120706.html

Medical device safety alert: pace medical micro-pace™ dual-chamber temporary cardiac pacemaker, ref 4580 it has come to our attention that medical device manufacturer, pace medical, inc. has initiated a field safety corrective action concerning micro-pace™ dual-chamber temporary cardiac pacemaker, ref 4580. the manufacturer has had isolated reports of intermittent sensing issues with the affected product. under some circumstances, the affected device would fail to resume nominal sense operation once the programmed rate was lowered or became lower than the patients intrinsic rate. this was determined to be associated with depolarization of the regions surrounding the patient leads. with higher lead impedances the region surrounding the patient lead would take longer than expected to depolarize. this resulted in an extended offset period, which interfered with the device’s differential sense input amplifier. decreasing the device’s input impedance to 10k solved the depolarization effect allowing nominal sense operation with maximal rates and programmed outputs. a simple hardware change eliminates the potential for this occurrence. the manufacturer advised users that: they should return the affected product for complimentary upgrade. they may use the device while scheduling product return; however it is recommended that patients are monitored while the device is in use and that the device is not used with patients with “heart wires” until the modification has been made to the device. if you are in possession of the product, please contact your supplier for necessary actions. posted on 6 july 2012.