MAUDE Adverse Event Report: MEDTRONIC, INC. PROGRIP MESH; MESH, SURGICAL, POLYMERIC

Model Number 10884521513143

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Weight Changes (2607); Hyponatremia (4494); Hormonal Imbalance (4495); Unspecified Musculoskeletal problem (4535)

Event Date 12/06/2021

Event Type  Injury  

Event Description

Right inguinal hernia repair using progrip mesh at (b)(6) in (b)(6) by dr (b)(6).Within a month i developed hyponitremia, then syndrome of inappropriate antidiuretic hormone (siadh) and have been diagnosed recently with complex regional pain syndrome (crps).I am now disabled.I had the progrip mesh removed (b)(6) 2022 in an attempt to save my life.I have many blood tests which document the start date and progression of the hyponitremia and the siadh.I also have had numerous ct scans, neurological tests, er visits and mris in the last 7 months, all have shown that there is no other cause to be found for my severe pain, weight loss, atrophy and disability.I am scheduled for a pet scan on (b)(6) and autonomic testing later this month.Fda safety report id# (b)(4).

• Brand Name: PROGRIP MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 15067489
• MDR Text Key: 296348289
• Report Number: MW5110997
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 10884521513143
• Device Lot Number: LPG1510X2
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN; BACLOFEN FOR THE MUSCLE CRAMPS AND PAIN; CBD; FOSOMAX FOR THE CRPS; MAGNESIUM ; SALT PILLS FOR THE HYPONOTREMIA; VIT C
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White