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Model Number LPG1510AK2 |
Device Problems
Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Emotional Changes (1831); Inflammation (1932); Nerve Damage (1979); Pain (1994); Pulmonary Dysfunction (2019); Scar Tissue (2060); Scarring (2061); Seroma (2069); Swelling (2091); Hernia (2240); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Ambulation Difficulties (2544); Abdominal Distention (2601); No Code Available (3191); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Event Description
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The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The preoperative diagnosis was right inguinal hernia.The procedure performed was a repair of the hernia with mesh, plug and patch technique.The product has caused the patient severe and permanent bodily injuries, including but not limited to excruciating abdominal pain and swelling, difficulty walking, and physical pain and suffering, and economical loss.Additionally, the patient will have to undergo subsequent surgeries to remove and/or repair the damage and injuries caused by the products.
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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 resulting in an unspecified adverse outcome.The product was used for therapeutic treatment.The preoperative diagnosis was right inguinal hernia.The procedure performed was a repair of the hernia with mesh, plug and patch technique.It was reported that after the procedure, the patient experienced excruciating abdominal pain, abdominal swelling, difficulty walking, pain and suffering, economical losses, scarring, hernia recurrence, and mesh 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 inguinal hernia.The procedure performed was a repair of the hernia with mesh, plug and patch technique.It was reported that after the procedure, the patient experienced excruciating abdominal pain, abdominal swelling, difficulty walking, pain and suffering, economical losses,scarring, hernia recurrence.Post-operative patient treatment included revision surgery.
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Manufacturer Narrative
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This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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 inguinal hernia in a laparoscopic repair.The procedure performed was a repair of the hernia with mesh, plug and patch technique.It was reported that after the procedure, the patient experienced excruciating abdominal pain, abdominal swelling, difficulty walking, pain and suffering, economical losses, scarring, hernia recurrence.Post-operative patient treatment included revision surgery and repair of hernia with mesh.
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Manufacturer Narrative
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This information was received as a part of an extensive mesh litigation submission to medtronic. the fda was notified of this large complaint receipt. due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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 inguinal hernia.The procedure performed was a repair of the hernia with mesh, plug and patch technique.It was reported that after the procedure, the patient experienced excruciating abdominal pain, abdominal swelling, difficulty walking, pain and suffering, economical losses,scarring, hernia recurrence.Post-operative patient treatment included revision surgery and repair of hernia with mesh.
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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 laparoscopic therapeutic treatment of an inguinal hernia.It was reported that after the procedure, the patient experienced defective device, mental pain, permanent impairment, loss of enjoyment of life, scarring, bulge, complete disruption of mesh, inflammation, nerve damage, excruciating abdominal pain, abdominal swelling, difficulty walking, pain, scarring, hernia recurrence.Post-operative patient treatment included revision surgery and repair of hernia with mesh.
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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 laparoscopic therapeutic treatment of an inguinal hernia.It was reported that after the procedure, the patient experienced seroma, disruption of mesh, large hydrocele on right side of scrotum that can be uncomfortable and unsightly/grotesque, defective device, mental pain, permanent impairment, loss of enjoyment of life, scarring, bulge, complete disruption of mesh, inflammation, nerve damage, excruciating abdominal pain, abdominal swelling, difficulty walking, pain, scarring, hernia recurrence.Post-operative patient treatment included ct scan, medication, revision surgery and repair of hernia with mesh.
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Manufacturer Narrative
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Additional info: a4, b5, b7, h4, h6 (patient codes, imf code, ime e2402: "hydrocele").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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