Product: Pacemaker Cardiac Resynchronization Therapy (M-CRT) InSync III. Model (s): 8042, 8042B and 8042U. Anvisa Registry n ° 10339190158. 의 안전성 경고

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Unexpected high battery impedance may result in the inability of the battery to provide sufficient electrical current, impacting the operation of the device. Twelve (12) of the 30 devices (devices that reported failure) reported unexpected loss of pacing. The other 18 devices exhibited some inappropriate behavior, including premature elective replacement (ERI) indication, significant fluctuations in estimates of remaining longevity and imprecise electrode impedances. As of October 27, 2015, the events associated with this problem occurred on devices with an implant period of 53 months or more. Medtronic received a patient death report, for which it is possible, but not confirmed, that this problem may have been a contributing factor. If rhythm capture is compromised, some patients may experience a return of symptoms of heart failure due to loss of biventricular rhythm. In cases involving pacemaker dependent patients, a loss of rhythm capture can result in severe injury or death.