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Model Number PCO3020X |
Device Problems
Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Diarrhea (1811); Purulent Discharge (1812); Edema (1820); Emotional Changes (1831); Erythema (1840); Fistula (1862); Hemorrhage/Bleeding (1888); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Seroma (2069); Chills (2191); Hernia (2240); Ulcer (2274); Anxiety (2328); Distress (2329); Injury (2348); Impaired Healing (2378); Diaphoresis (2452); Ascites (2596); Blood Loss (2597); Weight Changes (2607); Fluid Discharge (2686); Fibrosis (3167); No Code Available (3191); Unspecified Tissue Injury (4559); Decreased Appetite (4569); Swelling/ Edema (4577); 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 incarcerated complex ventral hernias (at least 3).It was reported that after implant, the patient experienced recurrence, abscess, ulcer, sinus tract, adhesions, chronic wound healing issues, bleeding, severe pain, nausea, diarrhea, cold sweats, inflammation, loss of appetite, extreme weight loss, infection and bleeding complication during a procedure to treat chronic abdominal wound.Post-operative patient treatment included surgical interventions.The patient has ongoing medical issues including the need for future medical treatment.
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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 incarcerated complex ventral hernias (at least 3).It was reported that after implant, the patient experienced recurrence, abscess, ulcer, sinus tract, adhesions, chronic wound healing issues, bleeding, severe pain, nausea, diarrhea, cold sweats, inflammation, loss of appetite, extreme weight loss, infection, bleeding complication during a procedure to treat chronic abdominal wound, bacterial infection, excoriation on the skin, and tissue edematous.Post-operative patient treatment included surgical interventions.The patient has ongoing medical issues including the need for future medical treatment.
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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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(removed c50603) additional information: g4 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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Patient codes - e2402 (sinus tract, loss of appetite, excoriation on skin).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 incarcerated complex ventral hernias (at least 3).It was reported that after implant, the patient experienced emotional distress, defective device, physical and mental pain, mental anguish, disability, impairment, loss of enjoyment of life, recurrence, abscess, ulcer, sinus tract, adhesions, chronic wound healing issues, bleeding, severe pain, nausea, diarrhea, cold sweats, inflammation, loss of appetite, extreme weight loss, infection, draining wound, bleeding complication during a procedure to treat chronic abdominal wound, bacterial infection, excoriation on the skin, and tissue edematous.Post-operative patient treatment included surgical interventions, excision of wound and sinus tract, veraflow dressing placed, incision and drainage of wound, removal of mesh, primary repair of abdomen.
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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 incarcerated complex ventral hernias (at least 3).It was reported that after implant, the patient experienced emotional distress, defective device, physical and mental pain, mental anguish, disability, impairment, loss of enjoyment of life, recurrence, abscess, ulcer, sinus tract, adhesions, chronic wound healing issues, bleeding, severe pain, nausea, diarrhea, cold sweats, inflammation, loss of appetite, extreme weight loss, infection, draining wound, bleeding complication during a procedure to treat chronic abdominal wound, bacterial infection, excoriation on the skin, fistula, anxiety, emotional distress, and tissue edematous.Post-operative patient treatment included surgical interventions, excision of wound and sinus tract, veraflow dressing placed, incision and drainage of wound, removal of mesh, primary repair of abdomen, and ct-scan.Relevant tests/lab data: on (b)(6) 2017 op note: ct scan demonstrated areas of 10cm involved deep over the muscle fascia.
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Manufacturer Narrative
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Additional information: g1 (manufacturer name, first name, last name, street 1, city, region, postal code, email, phone), h6 (patient codes).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 incarcerated complex ventral hernias (at least 3).It was reported that after implant, the patient experienced emotional distress, defective device, p hysical/mental pain, mental anguish, disability, impairment, loss of enjoyment of life, recurrence, abscess, ulcer, sinus tract, adhesions, chronic wound healing issues, bleeding, severe pain, nausea, diarrhea, cold sweats, inflammation, loss of appetite, extreme weight loss, infection, draining wound, bleeding complication during a procedure to treat chronic abdominal wound, bacterial infection, excoriation on the skin, fistula, anxiety, emotional distress, tissue edematous, staph infection, abnormal levels of white blood count; hemoglobin; hematocrit, dermal fibrosis, skin around jp drains are erythematous and raw, swelling, fluid collection, seroma, non-healing skin ulcer, tan bloody drainage from wound, <(>&<)> yellow-green discharge from wound.Post-operative patient treatment included surgical interventions, excision of wound and sinus tract, veraflow dressing placed, incision and drainage of wound, removal of mesh, primary repair of abdomen, ct-scan, jp drain removal, aspiration of serosanguinous fluid, antibiotics, antifungal, pain medication, cauterization of wound site, wound irrigation, negative pressure wound therapy, wound vac, <(>&<)> exploratory laparotomy.
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Manufacturer Narrative
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Additional info: a4, a5a, a5b, b5, b6, b7, <(>&<)> h6 (patient codes, ime e2402: abnormal levels of white blood count; hemoglobin; hematocrit).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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