Model Number 4543 |
Device Problems
Failure to Capture (1081); Fracture (1260); High impedance (1291); Pocket Stimulation (1463)
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Patient Problem
Device Overstimulation of Tissue (1991)
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Event Date 08/19/2021 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that one of the leads was fractured and the patient was experiencing extracardiac stimulation causing thumping.The patient was advised not to lay on the left side which helped mitigate symptoms.To date, the lead remains in service.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that one of the leads was fractured and the patient was experiencing extracardiac stimulation causing thumping.The patient was advised not to lay on the left side which helped mitigate symptoms.Additional information indicated that this lead was surgically abandoned due to high pacing impedance measurement greater than 2000 ohms and loss of capture.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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