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| Model Number 8888413807 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Hypersensitivity/Allergic reaction (1907); Respiratory Insufficiency (4462); Angioedema (4536); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 05/04/2023 |
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Event Type
Injury
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Manufacturer Narrative
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H6 patient codes - e2402 (subcutaneous emphysema) 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, there had been complications with a catheter in the patient.The catheter was placed into the patient and hours later facial edema and respiratory distress were presented, requiring hospitalization, support and control were carried out after placement.In addition, they reported that the catheter cracked along the radiopaque line.As a differential diagnosis, subcutaneous emphysema and allergic reaction to the catheter were considered.The patient improved after a couple of days of hospitalization.After discharge, the patient continued with the training to start pd (peritoneal dialysis).The patient finished the same and at the day peritoneal dialysis was going to start, the patient suffered a traumatic injury to the catheter (lacing catheter lesion, parallel to the radiopaque line) a few centimeter from the exit orifice, requiring its removal.It was mentioned that the device was not replaced to resolve the issue and procedure was completed.It was also mentioned that a catheter leak was recorded in the area of crack, the patient allegedly fell and bumped the catheter.The catheter was sent to (b)(6) (headquarter of the hospital) and when it was analyzed it caused an allergic reaction on the face of the doctor.The patient's first dialysis treatment began on (b)(6) 2022 and the patient's first dialysis in (b)(6) clinic started on (b)(6) 2023.The patient was admitted to the clinic at 1123 ((b)(6) 2023 or or (b)(6) 2023).Upon admission, the patient presented facial edema in which as reported began yesterday and had gradually increased which has not been established with the placement of corticosteroids, the airway impresses well in the same way it was referred for evaluation and possible hospitalization, the patient was admitted to other hospital for hemodialysis treatment.Tego was not utilized and there was no luer adapter issue.The catheter was not repaired.Iodine-topical solution was the cleaning agent used on the device and used to clean the insertion site prior to product placement.There was nothing unusual observed on the device prior to use and flushing was done prior to use with normal result.There was no blood loss and blood transfusion was not required.The patient was in stable condition.It was mentioned that there was no favorable reaction to corticoids.Ct scan and diagnostic orotracheal fistula were performed in other hospital as medical treatment as a result of the event.Based from the clinical summary in the month of (b)(6) 2023 the patient was hospitalized in a regular general condition.On (b)(6) 2023 the patient was in the medical clinic department.At (arterial/blood pressure) was 140/60 and during the treatment there were no complications, hemodialysis (hd) was stable, and at was 130/70.On (b)(6) 2023 at was 120/70, the programmed uf (ultrafiltration) was 2000 ml, no complications during treatment, hd was stable and at was 100/60.A significant facial edema did not allow for palpebral opening, distortion of the voice and breathing exam was normal.On (b)(6) 2023 at was 110/70, the programmed uf was 2000 ml and during the treatment, there were no complications.It was said that emphysema was due to an allergic reaction and therefore the orotracheal fistula was performed.A ct scan and a diagnostic oral-tracheal fistula were performed and also quasi-lenty of the emphysema, therefore surgery was scheduled for correction of the same, hemodialysis was stable and bp (blood pressure) was 110/70.On (b)(6) 2023 at was 110/70, programmed uf was 2000ml, oral fistula surgery was performed, the patient evolved favorably with less facial edema during treatment, there were no complications, hd termination was stable, at esd was 110/70.The patient continued hospitalization with favorable progression post-surgery.On (b)(6) 2023 the patient was in better general condition, facial edema decreased, ta was 110/70, the programmed uf was 2000ml, during the treatment there were no complications, hd termination was stable, ta was 100/60.The patient continued to be hospitalized with favorable progression, discharge assessed for hemodynamic stability.On (b)(6) 2023 the patient was discharged from (b)(6) and continued with hd at the site (b)(6) de parkinson¿s due to hemodynamic stability, after correction of oral-tracheal fistula, it was indicated to continue with chronic hemodialysis treatment at three-weeks.The patient had to continue with peritoneal dialysis training.The following were the intra-dialysis medication: eythropoietin: 8,000 iu (units)/week, iron: 0 mg/month, calcium acetate: 3 tablets/day, calcium carbonate: not indicated during the month because calcium was within normal parameters, calcitriol: 4 tablets/post hd, b complex: 1 tablet/post hd and folic acid 1 tablet/post hd.For the month of (b)(6) 2023 the patient was admitted in good general condition, pre and post-dialysis glycemia were not recorded for lack of reagents.On (b)(6) 2023 bp (blood pressure) was 140/70, pre-dialysis weight was 81 kg (kilogram), dry weight was 80 kg, uncomplicated during treatment, stable removal, bp was 110/80 and post-dialysis weight was 79.8 kg.The patient was training for switch mode.On (b)(6) 2023 bp was 140/70, pre-dialysis weight was 80.7 kg, dry weight was 80 kg, during treatment it was uncomplicated, stable removal, bp was 110/60 and post-dialysis weight was 80.3 kg.The patient had peritoneal dialysis training with good adhesion.On (b)(6) 2023 at was 110/70, pre-dialysis weight was 82.1 kg, dry weight was 80 kg, uncomplicated during treatment, stable withdrawn, at was 110/70 and post-dialysis weight 80.9 kg.On (b)(6) 2023 at was 120/70, pre-dialysis weight was 82.1 kg, dry weight was 80 kg, during treatment it was uncomplicated, stable removal, at was 110/70 and post-dialysis weight was 80.5 kg.The patient attended pre-hd peritoneal training with family members (child).On (b)(6) 2023 at was 130/60, pre-dialysis weight was 81 kg, dry weight was 80 kg, during treatment it was uncomplicated, stable removal, at was 120/70 and post-dialysis weight was 81.4 kg.They began peritoneal dialysis, the patient attended on wednesday for follow-up and then completed the hd session.On (b)(6) 2023, the patient changed 1 liter of home infusion without complications, it was monitored by the pd nurse.It continued with this mode on friday for a new check up.
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Event Description
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According to the reporter, there had been complications with a catheter in the patient.The catheter was placed into the patient and hours later facial edema and respiratory distress were presented, requiring hospitalization, support and control were carried out after placement.As a differential diagnosis, subcutaneous emphysema and allergic reaction to the catheter were considered.The patient was admitted to the clinic at 1123.Upon admission, the patient presented facial edema in which as reported began yesterday (on (b)(6) 2023) and had gradually increased which has not been established with the placement of corticosteroids, the airway impresses well in the same way it was referred for evaluation and possible hospitalization.Tego was not utilized and there was no luer adapter issue.The catheter was not repaired and not replaced.Iodine-topical solution was the cleaning agent used on the device and used to clean the insertion site prior to product placement.There was nothing unusual observed on the device prior to use and flushing was done prior to use with normal result.There was no blood loss and blood transfusion was not required.Procedure was completed.The patient was in stable condition.It was mentioned that there was no favorable reaction to corticoids.Ct scan and diagnostic orotracheal fistula were performed in other hospital as medical treatment as a result of the event.The patient was not admitted into the intensive care unit but remained hospitalized in the medical clinic room.The patient improved after a couple of days of hospitaliz ation.After discharge, the patient continued with the training to start pd (peritoneal dialysis).The patient's first dialysis treatment began on (b)(6) 2022 and the patient's first dialysis in dialmed clinic started on (b)(6) 2023.Based from the clinical summary in the month of (b)(6) 2023, the patient was hospitalized in a regular general condition.On (b)(6) 2023, the patient was in the medical clinic department.At (arterial/blood pressure) was 140/60 and during the treatment there were no complications, hemodialysis (hd) was stable, and at was 130/70.On (b)(6) 2023, at was 120/70, the programmed uf (ultrafiltration) was 2000 ml, no complications during treatment, hd was stable and at was 100/60.A significant facial edema did not allow for palpebral opening, distortion of the voice and breathing exam was normal.On (b)(6) 2023, at was 110/70, the programmed uf was 2000 ml and during the treatment, there were no complications.It was said that emphysema was due to an allergic reaction and therefore the orotracheal fistula was performed.A ct scan and a diagnostic oral-tracheal fistula were performed and also quasi-lenty of the emphysema, therefore surgery was scheduled for correction of the same, hemodialysis was stable and bp (blood pressure) was 110/70.On (b)(6) 2023 , at was 110/70, programmed uf was 2000ml, oral fistula surgery was performed, the patient evolved favorably with less facial edema during treatment, there were no complications, hd termination was stable, at esd was 110/70.The patient continued hospitalization with favorable progression post-surgery.On (b)(6) 2023, the patient was in better general condition, facial edema decreased, ta was 110/70, the programmed uf was 2000ml, during the treatment there were no complications, hd termination was stable, ta was 100/60.The patient continued to be hospitalized with favorable progression, discharge assessed for hemodynamic stability.On (b)(6) 2023, the patient was discharged from hospital italiano and continued with hd at the site dialmed de parkinson¿s due to hemodynamic stability, after corr ection of oral-tracheal fistula, it was indicated to continue with chronic hemodialysis treatment at three-weeks.The patient had to continue with peritoneal dialysis training.The following were the intra-dialysis medication: eythropoietin: 8,000 iu (units)/week, iron: 0 mg/month, calcium acetate: 3 tablets/day, calcium carbonate: not indicated during the month because calcium was within normal parameters, calcitriol: 4 tablets/post hd, b complex: 1 tablet/post hd and folic acid 1 tablet/post hd.For the month of (b)(6) 2023, the patient was admitted in good general condition, pre and post-dialysis glycemia were not recorded for lack of reagents.On (b)(6) 2023: bp (blood pressure) was 140/70, pre-dialysis weight was 81 kg (kilogram), dry weight was 80 kg, uncomplicated during treatment, stable removal, bp was 110/80 and post-dialysis weight was 79.8 kg.The patient was training for switch mode.On (b)(6) 2023, bp was 140/70, pre-dialysis weight was 80.7 kg, dry weight was 80 kg, during treatment it was uncomplicated, stable removal, bp was 110/60 and post-dialysis weight was 80.3 kg.The patient had peritoneal dialysis training with good adhesion.On (b)(6) 2023, at was 110/70, pre-dialysis weight was 82.1 kg, dry weight was 80 kg, uncomplicated during treatment, stable withdrawn, at was 110/70 and post-dialysis weight 80.9 kg.On (b)(6) 2023, at was 1 20/70, pre-dialysis weight was 82.1 kg, dry weight was 80 kg, during treatment it was uncomplicated, stable removal, at was 110/70 and post-dialysis weight was 80.5 kg.The patient attended pre-hd peritoneal training with family members (child).On (b)(6) 2023, at was 130/60, pre-dialysis weight was 81 kg, dry weight was 80 kg, during treatment it was uncomplicated, stable removal, at was 120/70 and post-dialysis weight was 81.4 kg.They began peritoneal dialysis, the patient attended on wednesday for follow-up and then completed the hd session.On (b)(6) 2023, the patient changed 1 liter of home infusion without complications, it was monitored by the pd nurse.It continued with this mode on friday for a new check up.
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Manufacturer Narrative
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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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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, there had been complications with a catheter in the patient.The catheter was placed into the patient and hours later facial edema and respiratory distress were presented, requiring hospitalization, support and control were carried out after placement.As a differential diagnosis, subcutaneous emphysema and allergic reaction to the catheter were considered.It was mentioned that the catheter was related to facial edema and swelling.The patient was admitted to the clinic at 1123.Upon admission, the patient presented facial edema in which as reported began yesterday and had gradually increased which has not been established with the placement of corticosteroids, the airway impresses well in the same way it was referred for evaluation and possible hospitalization.Tego was not utilized and there was no luer adapter issue.The catheter was not repaired and not replaced.Iodine-topical solution was the cleaning agent used on the device and used to clean the insertion site prior to product placement.There was nothing unusual observed on the device prior to use and flushing was done prior to use with normal result.No other products were utilized with the device.There was no blood loss and blood transfusion was not required.Procedure was completed.The patient was in stable condition.It was mentioned that there was no favorable reaction to corticoids.Ct scan and diagnostic orotracheal fistula were performed in other hospital as medical treatment as a result of the event.The patient was not admitted into the intensive care unit but remained hospitalized in the medical clinic room.The patient improved after a couple of days of hospitalization.After discharge, the patient continued with the training to start pd (peritoneal dialysis).The patient's first dialysis treatment began on (b)(6) 2022 and the patient's first dialysis in (b)(6) clinic started on (b)(6) 2023.Based from the clinical summary in the month of (b)(6) 2023, the patient was hospitalized in a regular general condition.On (b)(6) 2023, the patient was in the medical clinic department.At (arterial/blood pressure) was 140/60 and during the treatment there were no complications, hemodialysis (hd) was stable, and at was 130/70.On (b)(6) 2023, at was 120/70, the programmed uf (ultrafiltration) was 2000 ml, no complications during treatment, hd was stable and at was 100/60.A significant facial edema did not allow for palpebral opening, distortion of the voice and breathing exam was normal.On (b)(6) 2023, at was 110/70, the programmed uf was 2000 ml and during the treatment, there were no complications.It was said that emphysema was due to an allergic reaction and therefore the orotracheal fistula was performed.A ct scan and a diagnostic oral-tracheal fistula were performed (patient had required an emergency procedure to facilitate breathing) and also qu asi-lenty of the emphysema, therefore surgery was scheduled for correction of the same, hemodialysis was stable and bp (blood pressure) was 110/70.On (b)(6) 2023 , at was 110/70, programmed uf was 2000ml, oral fistula surgery was performed, the patient evolved favorably with less facial edema during treatment, there were no complications, hd termination was stable, at esd was 110/70.The patient continued hospitalization with favorable progression post-surgery.On (b)(6) 2023, the patient was in better general condition, facial edema decreased, ta was 110/70, the programmed uf was 2000ml, during the treatment there were no complications, hd termination was stable, ta was 100/60.The patient continued to be hospitalized with favorable progression, discharge assessed for hemodynamic stability.On (b)(6) 2023, the patient was discharged from hospital (b)(6) and continued with hd at the site (b)(6) due to hemodynamic stability, after correction of oral-tracheal fistula, it was indicated to continue with chronic hemodialysis treatment at three-weeks.The patient had to continue with peritoneal dialysis training.The following were the intra-dialysis medication: eythropoietin: 8,000 iu (units)/week, iron: 0 mg/month, calcium acetate: 3 tablets/day, calcium carbonate: not indicated during the month because calcium was within normal parameters, calcitriol: 4 tablets/post hd, b complex: 1 tablet/post hd and folic acid 1 tablet/post hd.For the month of (b)(6) 2023, the patient was admitted in good general condition, pre and post-dialysis glycemia were not recorded for lack of reagents.On (b)(6) 2023: bp (blood pressure) was 140/70, pre-dialysis weight was 81 kg (kilogram), dry weight was 80 kg, uncomplicated during treatment, stable removal, bp was 110/80 and post-dialysis weight was 79.8 kg.The patient was training for switch mode.On (b)(6) 2023 bp was 140/70, pre-dialysis weight was 80.7 kg, dry weight was 80 kg, during treatment it was uncomplicated, stable removal, bp was 110/60 and post-dialysis weight was 80.3 kg.The patient had peritoneal dialysis training with good adhesion.On (b)(6) 2023, at was 110/70, pre-dialysis weight was 82.1 kg, dry weight was 80 kg, uncomplicated during treatment, stable withdrawn, at was 110/70 and post-dialysis weight 80.9 kg.On (b)(6) 2023, at was 120/70, pre-dialysis weight was 82.1 kg, dry weight was 80 kg, during treatment it was uncomplicated, stable removal, at was 110/70 and post-dialysis weight was 80.5 kg.The patient attended pre-hd peritoneal training with family members (child).On (b)(6) 2023, at was 130/60, pre-dialysis weight was 81 kg, dry weight was 80 kg, during treatment it was uncomplicated, stable removal, at was 120/70 and post-dialysis weight was 81.4 kg.They began peritoneal dialysis, the patient attended on wednesday for follow-up and then completed the hd session.On (b)(6) 2023, the patient changed 1 liter of home infusion without complications, it was monitored by the pd nurse.It was said that the catheter was ready to be withdrawn.It was requesting its withdrawal with the customer area.It continued with this mode on friday for a new check up.
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Manufacturer Narrative
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Evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted one argyle catheter.It was reported that there was an adverse event with no alleged device issue.A potentially related device issue could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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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Additional information:b7, d9, g3, h3, h6 h3.Evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted no visual abnormalities.The device had been used in a clinical setting.There was no indication of any device property that could have contributed to the facial edema experience by the patient.It was reported that there was an adverse event with no alleged device issue.A potentially related device issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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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Search Alerts/Recalls
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