Model Number 4968-35 |
Device Problems
High impedance (1291); Capturing Problem (2891); Impedance Problem (2950)
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Patient Problems
Bradycardia (1751); Dizziness (2194)
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Event Date 04/02/2024 |
Event Type
Injury
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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It was reported that the patient experienced a low heart rate and dizziness.An interrogation report indicated that the right ventricular (rv) exhibited an acute rise in thresholds and impedance and triggered an alert for high impedance.The lead remains in use.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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It was further reported that the patient presented to the emergency department and was admitted.The rv lead was reprogrammed from bipolar to unipolar, which improved capture and sensing.The rv lead remains in use.
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Search Alerts/Recalls
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