MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION NEUROSTIMULATOR GENERATOR AND PADDLE; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Health Effect - Clinical Codes	Headache (1880); Device Overstimulation of Tissue (1991); Pain (1994); Scar Tissue (2060); Ambulation Difficulties (2544); Cognitive Changes (2551)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Faulty neurostimulator generator /battery replacement with wrong (amd) malfunctioning implanted inside my spine in my lower and mid back.It was programmed incorrectly by the device manufacturer and burned the paddle inside my spine by overstimulating.The paddle and wiring is in the wrong placement and caused scar tissue.The operation to replace the faulty generator was stopped due to complications and i was sent to er by the anesthesiologist where they found lesions on my brain that where not there before he zapped and overstimulate me.The new generator was finally replaced and malfunctioning.Called multiple times to manufacturer and they said sorry, there's nothing they can do.Told me to turn off and wait for battery to die.The complications were horrific multiple er visits testing and torture of the malfunctioning devices inside my body.The doctor said it may be a lemon and the manufacturers¿ representatives all agreed it was in wrong place, malfunctioning and must come out and all apologize.Sorry i'm going through all this; i finally had it removed (b)(6) and have the malfunctioning machine and the report that was to be sent back to the manufacturer for warranty credit noting and checking the box for complications associated with device.Also, the operation was to remove the complete system and risks of paralysis t6 down high.I now have additional complications and losing more functions of my legs and cognitive functions, headaches, and pain.The scars and lesions and complications have left me disabled and with forearm crutches.The manufacturer has sent me letters sensitive and confidential passing blame.I have had multiple doctors, tests, imagining and the 2 machines.I have 10 incisions on my back and all machines failed and caused more damages.The manufacturer said sorry, and the (b)(6) attorney general said to contact a lawyer and the department of health.No lawyers will help and the department of health, i have to go in person after recovery.I have one more surgery to attempt to repair the multiple failed back surgeries and delays caused by the faulty medical equipment.I need help and i have reported this before all the horrific complications and interference to my entire body.

• Brand Name: NEUROSTIMULATOR GENERATOR AND PADDLE
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 21422666
• Report Number: MW5166556
• Device Sequence Number: 11473350
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 02/16/2025

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability; Hospitalization; Life Threatening; Other
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White