InSync III (pacemaker)

2017: A withdrawal of 100 thousand pacemakers because of defects

In March, 2017 it became known of a withdrawal of pacemakers of Medtronic InSync III because of problems with power supply. The service campaign concerned about 100 thousand devices sold worldwide.

Medtronic sent to regulators the message in which recognized that pacemakers of InSync III have higher number of power failures, than it was expected though all the same it is about a small number of incidents because of what it was difficult to find defect earlier.

nSync III pacemaker

Sometimes there could be an accidental failure, and it is impossible to tell whether there was this case single. When we began to see how the same problem arose at two, three and four patients, we at once addressed Medtronic — Jay Sengupta, the cardiologist of Institute of heart of Minneapolis in which 448 pacemakers of InSync III were implanted reported.

Fault mentions three models of pacemakers InSync III: 8042, 8042B and 8042U. From 100 thousand recalled devices about 22 thousand were already used by patients. However at most in 162 devices (i.e. it is less than 1% of the total number of the equipment) there can be failures of power supply, assured of Medtronic.

Medtronic stopped release of a line of InSync III in 2011 after an exit of new products in which the problem with a power supply did not appear thanks to modifed accumulators, the producer assured.

Medtronic knows of one case of death of the patient called by, presumably, specified failure in work of a pacemaker. FDA appropriated to this response the second class assuming extremely low probability of serious effects for the human health using the equipment which got under a response. Service life of pacemakers of Medtronic makes 6-8 years depending on the settings selected by the doctor.^[1]

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