This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv)/respiratory sensor that is related to a high impedance condition.Please see the description for more information regarding the specific circumstances of this event.
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It was reported that the patient implanted with this pacemaker felt unwell one day after the device replacement procedure and returned to the hospital.Loss of capture on the right ventricular (rv) channel was observed on the hospital monitoring equipment, with no syncope reported.During testing, pacing threshold measurements remains normal and stable.The output on the rv lead was increased to 7.5v and the mode was changed to vvi.After this reprogramming no other signs of loss of capture where observed.The patient was hospitalized and monitored.Four days later the field representative attended to check the device.There were two signal artifact monitor (sam) episodes stored showing high, out-of-range pacing impedance measurements on the right atrial (ra) and rv leads, with a flat electrogram and some non-cardiac signals.These were stored on the date the patient returned to the hospital.No noise was produced during troubleshooting.Device data was reviewed by engineering and technical services.It was noted an atr episode was stored before the sam episodes and showed appropriate sensing and pacing.The data showed there were no faults and device operation appeared normal.The field representative confirmed that at the time of the sam episodes, the patient was laying in the bed, already hospitalized and monitored.X-rays were reviewed, but were not sufficiently clear to verify whether the lead terminal pins were fully inserted into the device.Header.No adverse patient effects were reported.Available information indicates the patient remains hospitalized pending a resolution.The field representative later reported that the patient underwent a system explant and replacement procedure at another hospital and has since been discharged in good condition.
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