MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS SYMBOTEX; MESH, SURGICAL, POLYMERIC

Model Number SYM2520

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Atrial Fibrillation (1729); Failure of Implant (1924); Muscle Weakness (1967); Nausea (1970); Renal Failure (2041); Scar Tissue (2060); Seroma (2069); Electrolyte Imbalance (2196); Hernia (2240); Anxiety (2328); Distress (2329); Obstruction/Occlusion (2422); Low Oxygen Saturation (2477); Ascites (2596); Abdominal Distention (2601); Fluid Discharge (2686); Fibrosis (3167); Constipation (3274); Unspecified Tissue Injury (4559); 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 an abdominal hernia.It was reported that after implant, the patient experienced recurrent hernia due to failure of the mesh, adhesions to the failed mesh, and unincorporated mesh.Post-operative patient treatment included mesh revision surgery and mesh removal surgery.

Manufacturer Narrative

Correction: h6 ime e2402: early satiety.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

H6 (patient codes, ime e2402: ime e2402: ileus, abnormal levels of albumin; white blood cell count; hemoglobin; hematocrit, rapid ventricular response, loss of domain, decreased urine output, ambulation) 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 an abdominal hernia.It was reported that after implant, the patient experienced recurrent hernia due to failure of the mesh, adhesions to the failed mesh, unincorporated mesh with free floating lower aspect, dilation of small bowel/colon, several fluid collections, small seromas,abnormal levels of albumin; bun/creatinine ratio; white blood cell count; hemoglobin; hematocrit, gaseous distended large bowel, ileus, partial small bowel obstruction, atrial fibrillation, rapid ventricular response, stress, nausea, early satiety, anxiety, decreased bowel frequency, filmy exudate, slow return of bowel function, scarring of abdominal wall, fibrous tissue, loss of domain, acute renal failure, decreased urine output, decreased oxygen saturation with ambulation, generalized weakness.Post-operative patient treatment included mesh revision surgery, mesh removal surgery, ct scan, iv cardizem, iv amiodarone, pain management, ng tube, iv fluids, iv potassium replacement, lap lysis of adhesions, posterior component separation, hernia repair with mesh, jp drain, transfer to cvu [intermediate care cardiovascular unit with telemetry], lopressor, metoprolol, blood transfusions, nasal ca nnula oxygen, morphine pca.

• Brand Name: SYMBOTEX
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 12027069
• MDR Text Key: 257120722
• Report Number: 9615742-2021-01523
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190481
• UDI-Public: 10884521190481
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142908
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: SYM2520
• Device Catalogue Number: SYM2520
• Device Lot Number: PSH0321X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2023
• Date Device Manufactured: 08/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 90 KG