MAUDE Adverse Event Report: MEDTRONIC SOFAMOR SYMBOTEX MEDTRONIC INC

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Fever (1858); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Pain (1994); Vomiting (2144); Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

Surgery; in (b)(6) 2018, i had surgery to correct an incisional hernia that was the result of a davinci robotic gallbladder removal surgery in (b)(6) 2016. I was informed that hernia mesh would be used to repair the hernia, and this was the only option i was given. My doctor used symbotex by medtronic mesh and the hernia was repaired. From that time, i had recurrent stomach pain that i lived with and in (b)(6) 2020 i suffered a serious stomach episode at home which included severe pain with nausea and vomiting and diarrhea that last throughout the entire night, but i treated at home. In (b)(6) 2020, i again had the same type of episode but on this occasion, i went to the emergency room and was treated for a small bowel obstruction with ng tube and admission into the hospital for treatment. I had surgery in (b)(6) 2020 and found that my small bowel was twisted 180 degrees and adhered to my mesh. The surgeon cut my bowel away from my mesh, leaving mesh adhered to my bowel for fear of damaging the bowel itself and i was admitted to the hospital for what was supposed to be a day surgery due to the fact that i got a fever and had uncontrolled pain and low blood pressure. The issue with my mesh has caused me to miss multiple days from my job and pain/suffering as well as numerous medical expenses. Fda safety report id # (b)(4).

• Brand Name: SYMBOTEX
• Type of Device: MEDTRONIC INC
• Manufacturer (Section D): MEDTRONIC SOFAMOR
• MDR Report Key: 11170195
• MDR Text Key: 227177376
• Report Number: MW5098824
• Device Sequence Number: 1
• Product Code: FTL

Combination Product (Y/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: 01/12/2021

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 01/13/2021
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: NO INFORMATION
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated By Manufacturer?

Is The Device Single Use?

Is this a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient TREATMENT DATA

Date Received: 01/13/2021 Patient Sequence Number: 1