MAUDE Adverse Event Report: UNKNOWN SIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 10/01/2010

Event Type  Injury  

Event Description

I had 2 surgeries one in 2010 and one in 2018 using (b)(6) to repair a ingunial hernia or that's what i was told was the problem.Every since the first surgery i have had medical problems that would have been consistent with a type of stimulator being inserted in multiple places around where i had surgery and it malfunctioning.Surgeons have denied the allegations but x-rays prove different.I believe these surgeons placed this in my body to do test for financial gain.I am in fear of them using this to try and kill me to keep this quiet.I need your help please direct me to someone to talk to about what's going on in the(b)(6) hospital system.

• Brand Name: SIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16584357
• MDR Text Key: 311821122
• Report Number: MW5115890
• Device Sequence Number: 1
• Product Code: EZW
• 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: 03/17/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability; Life Threatening
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White