|
Model Number LPG1510 |
Device Problems
Material Integrity Problem (2978); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Adhesion(s) (1695); Purulent Discharge (1812); Emotional Changes (1831); Erythema (1840); Fever (1858); Foreign Body Reaction (1868); Granuloma (1876); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Vasodilatation (2127); Hernia (2240); Distress (2329); Discomfort (2330); Impaired Healing (2378); Fluid Discharge (2686); Swollen Lymph Nodes/Glands (4432); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Type
Injury
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
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 chronic groin pain, scar tissue surrounding mesh, and scar formation from mesh implant.Post-operative patient treatment included revision surgery and mesh removal.
|
|
Event Description
|
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a right inguinal hernia.It was reported that after implant, the patient experienced emotional distress, mental pain, defective mesh, disability, loss of enjoyment of life, permanent impairment, dilation of spermatic vein, infection, hematoma, blood clot, purulence, inflammatory response, discomfort, mental anguish, chronic groin pain, scar tissue surrounding mesh, and scar formation from mesh implant.Post-operative patient treatment included revision surgery, removal of testicle, incision and drainage of hematoma, and mesh removal.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a right inguinal hernia.It was reported that after implant, the patient experienced bleeding, adhesions, recurrence, scarring, foreign body reaction, mesh shrinkage, suffering, testicular pain, emotional distress, mental pain, defective mesh, disability, loss of enjoyment of life, permanent impairment, dilation of spermatic vein, infection, hematoma, blood clot, purulence, inflammatory response, discomfort, mental anguish, chronic groin pain, scar tissue surrounding mesh, and scar formation from mesh implant.Post-operative patient treatment included mesh revision, partial mesh removal, revision surgery, removal of testicle, incision and drainage of hematoma, and mesh removal.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
Additional info: b2 (outcome attributed to adverse event), h6 (patient and health impact codes; e2402: low hemoglobin and hematocrit, atrophy of testis, hydrocele, varicocele, induration, skin sloughing, fluctuance).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.
|
|
Event Description
|
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a right inguinal hernia.It was reported that after implant, the patient experienced low hemoglobin and hematocrit, inflammation, spermatic granuloma, atrophy of testis, hydrocele, varicocele, lymphadenopathy, spermatic vein dilated, bloody scrotal drainage, fever, swelling, induration, erythema, skin sloughing, fluctuance, blood clot, open wound, bleeding, adhesions, recurrence, scarring, foreign body reaction, mesh shrinkage, suffering, testicular pain, emotional distress, mental pain, defective mesh, disability, loss of enjoyment of life, permanent impairment, dilation of spermatic vein, infection, hematoma, blood clot, purulence, inflammatory response, discomfort, mental anguish, chronic groin pain, scar tissue surrounding mesh, and scar formation from mesh implant.Post-operative patient treatment included home health support, iv fluids, admission to hospital, jp drain, antibiotics, ct scan, incision and drainage, mesh revision, partial mesh removal, revision surgery, removal of testicle, incision and drainage of hematoma, and mesh removal.
|
|
Search Alerts/Recalls
|
|
|