Model Number 977006 |
Device Problems
Premature Discharge of Battery (1057); Electromagnetic Compatibility Problem (2927)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Event Description
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Information was received from an hcp and manufacturing representative (rep) regarding a patient implanted with an implantable neurostimulator (ins).It was reported that the ins reached premature/abnormal battery depletion.The hcp indicated that they would like to know if the ins depleted at expected time with the patient's ins settings, or if it was premature discharge that could have occurred during the patient's recent coronary artery bypass surgery, if a possible internal cardioversion was or could have been performed at that time.The ins was explanted and replaced on (b)(6) 2023.The patient recovered without sequela.The ins was returned for analysis.
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Manufacturer Narrative
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H3: destructive analysis of the ins determined that there was abnormal function of an integrated circuit on the hybrid circuit board of the implantable neurostimulator (ins).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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Additional information from the hcp indicated that the patient's coronary artery bypass surgery occurred on (b)(6) 2022.The hcp clarified that the patient did not have a cardioversion procedure during their bypass surgery.
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Search Alerts/Recalls
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