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Model Number SYM20 |
Device Problems
Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
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Patient Problems
Adhesion(s) (1695); Emotional Changes (1831); Inflammation (1932); Nausea (1970); Pain (1994); Scar Tissue (2060); Seroma (2069); Vomiting (2144); Hernia (2240); Distress (2329); Obstruction/Occlusion (2422); Abdominal Distention (2601); Unspecified Tissue Injury (4559)
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Event Type
Injury
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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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The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced defective mesh, hole in mesh, pain, emotional distress, disability, impairment, loss of enjoyment of life, mental pain, recurrence, obstruction, adhesions, serosal tear, protrusion of colon, inflammation.Post-operative patient treatment included revision surgery, ct scan, takedown of adhesions, hernia repair.
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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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The patient's attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced suffering, defective mesh, hole in mesh, pain, emotional distress, disability, impairment, loss of enjoyment of life, mental pain, recurrence, obstruction, adhesions, serosal tear, protrusion of colon and inflammation.Post-operative patient treatment included hernia repair with additional mesh, serosal tear repair, exploratory laparotomy, revision surgery, ct scan, takedown of adhesions and ventral hernia repair.
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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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Additional info: a1, b2 (added hospitalization), h6 (patient codes, imf code).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.
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Event Description
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The patient's attorney alleged a deficiency against the device.The product was used for therapeutic laparoscopic treatment of an incisional hernia.It was reported that after implant, the patient experienced scarring, scar tissue, seroma, nausea, vomiting, stranding around loop of bowel, suffering, defective mesh, hole in mesh, pain, emotional distress, disability, impairment, loss of enjoyment of life, mental pain, recurrent hernia with incarceration, obstruction, adhesions, serosal tear, protrusion of colon and inflammation.Post-operative patient treatment included hospitalization, scar revision, application of prevena dressing, hernia repair with additional mesh, serosal tear repair, exploratory laparotomy, revision surgery, ct scan, takedown of adhesions and ventral hernia repair.
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Search Alerts/Recalls
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