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Model Number SYM12 |
Device Problems
Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Wound Dehiscence (1154); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Erosion (1750); Emotional Changes (1831); Erythema (1840); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Necrosis (1971); Pain (1994); Scar Tissue (2060); Scarring (2061); Seroma (2069); Chills (2191); Discharge (2225); Hernia (2240); Distress (2329); Injury (2348); Impaired Healing (2378); Ascites (2596); Fluid Discharge (2686); No Code Available (3191); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).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 the underlay implant, the patient experienced infected mesh, abscess, seroma, necrosis, adhesions, scarring, sinus tract, infection, nausea, chills, inflammation, recurrence, pain, fluid collection, discharge, lower half of umbilicus was dehisced, erythema, open wound and suffering.Post-operative patient treatment included revision surgery, removal of mesh, umbilicus resected, incision/drainage of abdomen, excisional debridement of skin/subcutaneous tissue, complex closure of wound, drain removed prematurely, abdominoplasty, abdominal washout, excision of sinus tract, incision/drainage of abscess, abdominal wall reconstruction, and drain placement.
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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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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 the underlay implant, the patient experienced infected mesh, abscess, seroma, necrosis, adhesions, scarring, sinus tract, infection, nausea, chills, inflammation, recurrence, pain, fluid collection, discharge, lower half of umbilicus was dehisced, erythema, open wound, inflammation, mental pain/anguish, disability, permanent impairment, loss of enjoyment of life, defective mesh, emotional distress, and suffering.Post-operative patient treatment included revision surgery, removal of mesh, umbilicus resected, incision/drainage of abdomen, excisional debridement of abscess/skin/subcutaneous tissue, complex closure of wound, drain removed prematurely, abdominoplasty, abdominal washout, excision of sinus tract, incision/drainage of abscess, abdominal wall reconstruction with new mesh, clearing of seroma/necrosis, and drain placement.
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Manufacturer Narrative
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Additional info: g2-4 (nda#, pma/510(k)#), h6 (patient codes, ime e2402: "sinus tract").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 treatment of an incisional hernia.It was reported that after the underlay implant, the patient experienced fistulae, infected mesh, abscess, seroma, necrosis, adhesions, scarring, sinus tract, infection, nausea, chills, inflammation, recurrence, pain, fluid collection, discharge, lower half of umbilicus was dehisced, erythema, open wound, mental pain/anguish, disability, permanent impairment, loss of enjoyment of life, defective mesh, emotional distress, and suffering.Post-operative patient treatment included revision surgery, removal of mesh, umbilicus resected, incision/drainage of abdomen, excisional debridement of abscess/skin/subcutaneous tissue, complex closure of wound, drain removed prematurely, abdominoplasty, abdominal washout, excision of sinus tract, incision/drainage of abscess, abdominal wall reconstruction with new mesh, clearing of seroma/necrosis, and drain placement.
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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 the underlay implant, the patient experienced fistulae, infected mesh, abscess, seroma, necrosis, adhesions, scarring, sinus tract, infection, nausea, chills, inflammation, recurrence, pain, fluid collection, discharge, lower half of umbilicus was dehisced, erythema, open wound, mental pain/anguish, disability, permanent impairment, loss of enjoyment of life, defective mesh, emotional distress, suffering, positive for staph; diphtheroids, abnormal levels of hemoglobin; hematocrit, fibrinous exudate, would healing issues, foreign bodies had eroded through abdominal wall.Post-operative patient treatment included revision surgery, removal of mesh, umbilicus resected, incision/drainage of abdomen, excisional debridement of abscess/skin/subcutaneous tissue, complex closure of wound, drain removed prematurely, abdominoplasty, abdominal washout, excision of sinus tract, incision/drainage of abscess, abdominal wall reconstruction with new mesh, clearing of seroma/necrosis, drain placement, ct scan, ultrasound guided aspiration of abdomen, as much mesh as possible removed, antibiotics.
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Search Alerts/Recalls
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