Model Number 6947M55 |
Device Problems
Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/24/2024 |
Event Type
Injury
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Manufacturer Narrative
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Correction: h6 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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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 presented to the emergency department due to hearing their device tone.Information received on a remote transmission was reviewed by qualified personnel.It was determined that the right ventricular (rv) lead triggered alerts for undefined high rv pacing impedance and undefined high rv and superior vena cava (svc) high voltage coil impedance.The lead had a confirmed fracture on the low voltage portion of the lead.Additionally, noise was observed during isometric movements.The following day the lead was capped and replaced.No patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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