MAUDE Adverse Event Report: ST. JUDE MEDICAL NEURO STIMULATOR IMPLANT; STIMULATOR ELECTRICAL IMPLANTED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Injury (2348)

Event Type  Other  

Event Description

You would not believe the horror and pain i have been through these past 3 years.In (b)(6) 2016 (b)(6), my husband had a neurostimulator implanted.These pictures are the results.Three years it took for the hole to close completely.He still has small particle of metal that push through the skin.They know, i know why, how, when, where all this took place; why, easy money.Report surgeries, a little accident in the operating room went wrong.The stimulator shattered.I contacted st jude medical, the maker of the unit.Of course they wouldn't help.Their product was not entirely safe.Three years i took care of my husband.I took care of him.I knew what they did, now in (b)(6) 2018, there was an mva, i stayed home that day.But in (b)(6) of 2019 they made sure i was driving, i suffered neck, back, leg and arm injuries, among others.They refuse to treat me, and are using my pain pump as a weapon to hurt me.All this can be proved.No police showed up at the mva until 1 1/2 hrs later.The insurance company never looked at the car which sat in the drive way almost a week.I've only gotten 3 "cks" for mileage.They have inflicted terrible things against us.We need help or they will continue what they are doing until it's too late for me.I waited a long time to report this because i wanted to be positive about what i know, and there is much more.I have to hide how i send out my mail.My phone is being tampered with.Please, please i have not done this with a light heart.I'm terrified, but im more scared of the alternative.Sincerely, (b)(6).

Event Description

Add'l info received from reporter 01/28/2020 for report mw5091085.My husband had a hole in his back for over 3 yrs, while metal cut its way out through his skin, that took 3 surgeries alone to accomplish.Not to mention other back surgeries, 2 hip replacements and surgery to repair the aneurisms they knew he had for almost 10 years.Ref mw5092561.

• Brand Name: NEURO STIMULATOR IMPLANT
• Type of Device: STIMULATOR ELECTRICAL IMPLANTED
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 9322283
• MDR Text Key: 167796974
• Report Number: MW5091085
• Device Sequence Number: 1
• Product Code: LGW
• 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 Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1