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Model Number CA15L2 |
Device Problems
Connection Problem (2900); Appropriate Term/Code Not Available (3191)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/12/2023 |
Event Type
Injury
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Event Description
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According to the reporter, during a procedure, the two antennas has not been detected by the generator, and the "?" alarm ("antenna not identified") remain displayed.Customer stated that it came from the cable because a procedure has been performed successfully previously the same day with the same cable, and after this event the antenna that worked on the previous procedure was not identified anymore as the two others, whereas it was well identified sooner. procedure was cancelled - patient was under anesthesia. it is planned to be rescheduled, but the date remains unknown yet.There was no patient injury.
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Manufacturer Narrative
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D10 concomitant product: ca190rc1 ca190rc1 ablation reusable cable x1 (serial# (b)(6)); ca20l2, ca20l2 20cm rein percutaneous antenna x1 (lot#s22hg007); cagenhp, hp ablation gen cagenhp (serial# (b)(6)).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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New information has been received pertaining to the event.This event has been reassessed and the reportability has been determined to be a serious injury.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during a procedure, the two antennas has not been detected by the generator, and the "?" alarm ("antenna not identified") remain displayed.The customer stated that it came from the cable because a procedure has been performed successfully previously the same day with the same cable, and after this event the antenna that worked on the previous procedure was not identified anymore as the two others, whereas it was well identified sooner. procedure was cancelled - patient under anesthesia. it is planned to be rescheduled, but the date remains unknown yet.
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Search Alerts/Recalls
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