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Model Number SPM-35 |
Device Problems
Material Perforation (2205); 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); Purulent Discharge (1812); Emotional Changes (1831); Gangrene (1873); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Perforation (2001); Tachycardia (2095); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); 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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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 a hernia.It was reported that after implant, the patient experienced adhesions, infection and recurrence.Post-operative patient treatment included revision surgery.
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Manufacturer Narrative
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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 incarcerated left inguinal hernia.It was reported that after implant, the patient experienced adhesions, infection, recurrence, strangulated left inguinal hernia containing perforated and gangrenous sigmoid colon, tachycardia, wound dehiscence, prolapsing colostomy, purulent drainage from left inguinal incision, open wound and chronic drainage of the left inguinal wound.Post-operative patient treatment included revision surgery, mesh removal, exploratory laparotomy, partial colectomy, colostomy, wound vac placement due to pneumoperitoneum, takedown of colostomy, lysis of adhesions, left inguinal wound exploration due to left inguinal hernia, parastomal hernia and left inguinal hernia wound.
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Manufacturer Narrative
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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 incarcerated left inguinal hernia.It was reported that after implant, the patient experienced adhesions, infection, recurrence, strangulated left inguinal hernia containing perforated and gangrenous sigmoid colon, tachycardia, wound dehiscence, prolapsing colostomy, purulent drainage from left inguinal incision, and chronic drainage of the left inguinal wound.Post-operative patient treatment included revision surgery.
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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 incarcerated left inguinal hernia.It was reported that after implant, the patient experienced adhesions, infection, recurrence, strangulated left inguinal hernia containing perforated and gangrenous sigmoid colon, tachycardia, wound dehiscence, prolapsing colostomy, purulent drainage from left inguinal incision, open wound, defective device, mental/physical pain, suffering, disability, impairment, loss of enjoyment of life, pneumoperitoneum, and chronic drainage of the left inguinal wound.Post-operative patient treatment included revision surgery, mesh removal, exploratory laparotomy, partial colectomy, colostomy, wound vac placement due to pneumoperitoneum, takedown of colostomy, lysis of adhesions, left inguinal wound exploration due to left inguinal hernia, parastomal hernia and left inguinal hernia wound.
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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 incarcerated left inguinal hernia.It was reported that after implant, the patient experienced pain, abscess, adhesions, infection, recurrence, strangulated left inguinal hernia containing perforated and gangrenous sigmoid colon, tachycardia, wound dehiscence, prolapsing colostomy, purulent drainage from left inguinal incision, open wound, defective device, mental/physical pain, suffering, disability, impairment, loss of enjoyment of life, pneumoperitoneum, and chronic drainage of the left inguinal wound.Post-operative patient treatment included ct-scan, medication, partial sigmoid reconstruction, revision surgery, mesh removal, exploratory laparotomy, partial colectomy, colostomy, wound vac placement due to pneumoperitoneum, takedown of colostomy, lysis of adhesions, left inguinal wound exploration due to left inguinal hernia, parastomal hernia and left inguinal hernia wound.Relevant tests/laboratory data: (b)(6) 2018: op note stated ct scan had demonstrated pneumoperitoneum.
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Search Alerts/Recalls
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