Dual Chamber Pacemakers | 合法醫療器材資訊網

2019年1月7日—Through4January2019,Medtronicisawareoffour(4)reportedoccurrencesintwo(2)patientswhereapauseinpacingtherapywasclinically ...

Through 4 January 2019, Medtronic is aware of four (4) reported occurrences in two (2) patients where a pause in pacing therapy was clinically apparent due to this circuit error. These reported events occurred in three (3) devices from a total of 156,957 devices sold worldwide. No deaths have been reported as a result of this issue.

Patient risk is determined by the patient’s underlying cardiac rhythm and whether the device is in a susceptible pacing mode as described above. Through our analysis of this issue, Medtronic estimates that on average, a device in a susceptible pacing mode has a 2.8% chance per month of experiencing a pacing pause of 1.5 seconds or longer. Risk is minimized in patients who have an escape rhythm adequate to prevent syncope during a loss of ventricular pacing, since a VS restores full device functionality. No risk of a pause due to this circuit error exists for patien...