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Model Number UNKNOWN PROGRIP |
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); Adhesion(s) (1695); Bruise/Contusion (1754); Ecchymosis (1818); Emotional Changes (1831); Hematoma (1884); Inflammation (1932); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Hernia (2240); Distress (2329); Discomfort (2330); Diaphoresis (2452); Ascites (2596); Fluid Discharge (2686); Constipation (3274); Syncope/Fainting (4411); Cough (4457); Cramp(s) /Muscle Spasm(s) (4521); 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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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 inguinal hernia.It was reported that after implant, the patient experienced mental anguish, defective device, mesh failure, pain, mental pain, inflammation, discomfort, impairment, emotional distress, disability, and loss of enjoyment of life.Post-operative patient treatment included revision surgery, mesh revision, removal of mesh, robotic groin exploration, and triple neurectomy.
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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 inguinal hernia.It was reported that after implant, the patient experienced adhesions, mesh migration, nerve damage, mental anguish, defective device, mesh failure, pain, mental pain, inflammation, discomfort, impairment, emotional distress, disability, and loss of enjoyment of life.Post-operative patient treatment included revision surgery, mesh revision, removal of mesh, robotic groin exploration, and triple neurectomy.
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Manufacturer Narrative
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Additional info: h6 (patient codes, ime e2402: abnormal hemoglobin hematocrit levels, induration, coughing).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 inguinal hernia.It was reported that after implant, the patient experienced adhesions, mesh migration, nerve damage, mental anguish, defective device, mesh failure, pain, mental pain, inflammation, discomfort, impairment, emotional distress, disability, loss of enjoyment of life, hematoma, small fluid collection, abnormal hemoglobin hematocrit levels, inguinodynia, drainage from incision, night sweats, bowel movement difficulty, scar tissue, coughing, bruising, swelling, syncopal episodes, difficulty urinating due to pain, hernia recurrence, constipation, abdominal pain, ecchymosis, induration, muscle spasms, difficulty sleeping due to pain.Post-operative patient treatment included revision surgery, mesh revision, removal of mesh, robotic groin exploration, triple neurectomy, ct scan, pain medication, anti-inflammatory medication, ultrasound, inguinodynia procedure, hernia repair with mesh, muscle spasm medication, hospitalization.
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Search Alerts/Recalls
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