MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION MEDTRONIC INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Health Effect - Clinical Codes	Emotional Changes (1831); Nerve Damage (1979); Pain (1994); Burning Sensation (2146); Inadequate Pain Relief (2388); Shock from Patient Lead(s) (3162)
Date of Event	10/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
I had the interstim implanted (b)(6) 2018 after the trial.After the permanent was placed it never worked properly or as well as the trial device.I began to have involuntary leg and foot movements and could not drive because it happened often, a few months after, the implant procedure it began shocking me and the implant site area was constantly burning and throbbing.I also had severe lower back pain as well as leg pain.I visited my urogynecologist, and it was reprogrammed several times, i was told it is possible it is sitting on the wrong nerve.The device becomes increasingly painful and the shocks increasing i was informed to turn the device off until my next follow up appointment.It was at this follow up that i discovered a discontinued model was used for my implant and that since she was not familiar with the old model, she would let me see a different doctor at my follow up.I ended up having the implant removed (b)(6) 2019.Since i have suffered nerve damage and pain, constant pain at the implant site.Lower back pain and hip pain.This has really caused a decline in my quality of life.I am unable to work even an office job but not disabled enough for disability benefits.I was sold a dream that this would fix my ic symptoms and off label reduce the associated pain.I feel like i was a mere pawn just so the salesman and doctor could make a profit.Furthermore, a known discontinued device was implanted.Doing research all i saw was good reviews from "patients" and how the interstim gave them their lives back but in a sense, it took my life.The nerve damage is so crippling at times that sometimes i wish for death.No one understands how it feels to be a guinea pig for profit.I pray that someone that is considering this device sees this and think long and hard about other options because the consequences can be lifelong.

• Brand Name: MEDTRONIC INTERSTIM II
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 20665805
• Report Number: MW5162373
• Device Sequence Number: 13968873
• Product Code: EZW
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 11/05/2024

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability; Other
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American