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

Model Number	LPG1510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hiccups (1899); Inflammation (1932); Nerve Damage (1979); Pain (1994); Tinnitus (2103); Burning Sensation (2146); Discomfort (2330); Sleep Dysfunction (2517); Ambulation or Postural Difficulties (2544); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Voice alteration (4906)
Date of Event	06/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after implantation of the mesh, severe pain occurred at the implant site, back, and legs upon waking after the operation.The individual experienced difficulty standing, sitting, and walking, as well as electric shocks in the legs.Persistent inflammation, nerve damage, and major functional disorders were noted.Chronic disabling pain in the pelvis and a burning sensation in the prosthesis area were described, along with adhesions of internal organs causing unbearable pain.Additional symptoms included difficulty speaking and loss of voice after meals, compression of the diaphragm, and tinnitus.The individual reported an inability to work since the operation, inability to walk or sit for more than 10 to 15 minutes without severe pain and electric shocks, inability to shop or make car journeys, and a painful lying position with tightness and muscle spasms that disturbed sleep.Sleep disturbance due to muscle spasms and tightness was also reported.Disability was recognized (rqth recognition since june 2024), and there was a loss of social life and inability to go on family outings.Chronic pain required follow-up at a chronic pain center, and psychological follow-up was also required.The individual expressed a feeling of deception by the surgeon and medical team, and noted that removal of the prosthesis would be difficult and associated with major risks and possible dangerous complications.There was concern about potential future tissue erosion caused by the prosthesis and possible damage to neighboring organs.The individual described a life-altering disability since the implantation.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PROGRIP
• Common Device Name: 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24750376
• Report Number: 9615742-2026-00352
• Device Sequence Number: 16035220
• Product Code: FTL
• UDI-Device Identifier: 10884521513136
• UDI-Public: (01)10884521513136(17)250331(10)PWD1407X(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K120897
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: LPG1510
• Device Catalogue Number: LPG1510
• Device Lot Number: PWD1407X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Unknown