Recall Z-1661-2014— Medtronic Inc. Cardiac Rhythm Disease Management

Class II FDA medical device recall by Medtronic Inc. Cardiac Rhythm Disease Management, initiated 2014-04-29, terminated 2014-10-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device is typically connected to temporary transvenous, epicardial or myocardial pacing leads, in a bipolar configuration, using a patient cable (Medtronic Model 5433A or 5433V) or a surgical cable (Medtronic Model 5832 or 5832S).. Reason: Events related to a pacing rate outside of the intended setting, including events of sudden increased pacing rate up to the maximum setting of 180 pulses per minute (ppm), have been reported. This is caused by the development of high resistance on internal electrical connector contacts due to oxidation over time..

Recalling firm

Medtronic Inc. Cardiac Rhythm Disease Management

Classification

Class II

Status

Terminated

Initiated

2014-04-29

Terminated

2014-10-08

Firm location

Saint Paul, MN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.