Model Number 6947M62 |
Device Problems
Fracture (1260); High impedance (1291)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/23/2024 |
Event Type
malfunction
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Event Description
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It was reported that an alert was triggered for the right ventricular (rv) lead due to a sudden increase in rv coil and superior vena cava (svc) coil impedances to high/undefined levels.An rv coil fracture was suspected.The lead remains in use. no patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Continuation of d10: product id ddpa2d4 (serial: (b)(6)); product type: 0235-icd; implant date (b)(6) 2023 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 right ventricular (rv) lead was later extracted and replaced.
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Manufacturer Narrative
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Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated the impedance of the right ventricular defibrillation coil was beyond the expected upper range.Analysis of the device memory indicated the impedance of the superior vena cava defibrillation coil was beyond the expected upper range.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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Search Alerts/Recalls
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