Device Problems
Pacing Problem (1439); Impedance Problem (2950); High Capture Threshold (3266)
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Patient Problems
Muscle Weakness (1967); Dizziness (2194); Loss of consciousness (2418); Syncope/Fainting (4411)
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Event Date 03/26/2023 |
Event Type
malfunction
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Event Description
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It was reported that the patient with this unknown endotak right ventricular (rv) lead has had symptoms of dizziness and weakness as well as a recent syncopal episode.It was noted that high pacing thresholds and a gradual decrease in rv lead pacing impedance were observed.The patient has known atrial fibrillation (af) and had an atrioventricular (av) node ablation in the beginning of 2022.The patient is dependent on pacing therapy (100% vp).The device was reprogrammed to vvir mode to avoid potential av crosstalk, and technical services (ts) was consulted for further review.In office lead troubleshooting was recommended.No additional adverse patient effects were reported.
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Manufacturer Narrative
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This unknown lead remains implanted; therefore, technical analysis cannot be conducted.Without a returned product it is not possible to definitively confirm how it may have contributed to the complaint incident.If pertinent information is provided in the future, a supplemental report will be submitted.
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Event Description
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It was reported that the patient with this unknown endotak right ventricular (rv) lead has had symptoms of dizziness and weakness as well as a recent syncopal episode.It was noted that high pacing thresholds and a gradual decrease in rv lead pacing impedance were observed.The patient has known atrial fibrillation (af) and had an atrioventricular (av) node ablation in the beginning of 2022.The patient is dependent on pacing therapy (100% vp).The device was reprogrammed to vvir mode to avoid potential av crosstalk, and technical services (ts) was consulted for further review.In office lead troubleshooting was recommended.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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