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

Device Problems Pocket Stimulation (1463); Malposition of Device (2616); Device Dislodged or Dislocated (2923); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); Rash (2033); Burning Sensation (2146); Electric Shock (2554); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

I had a medtronic interstim placed for urinary incontinence approximately in 2018.Immediately after surgery i experience extreme lower back pain and the battery that was placed in my right buttocks started to move around and completely flipped over.I then had to have a revision surgery to make a deeper pocket in hopes that would stop the battery from flipping over.That revision failed.I started to have more pain and my entire hip and buttocks started to swell.At that point it was decided to move the battery to my left buttocks.I continued to have severe lower back pain and pain in my buttocks on both sides.The interstim also flipped completely over in the new location.I then had another revision to make an even deeper pocket in hopes that it would not move.That also failed.My doctor then did another revision and sutured it to the muscle in my butt.I still had continued issues with the interstim.Ultimately, i ended up removing the entire device.As well as the device moving around it would also shock me periodically.That was also painful.Even though the interstim has been removed i still have lasting back pain with burning in both butt cheeks that radiates into my hips.I also developed a rash on my lower extremities because my body was trying to reject it.I had 2 placement surgeries and 3 revision surgeries.Fda safety report id # (b)(4).

• Brand Name: INTERSTIM
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 11885136
• MDR Text Key: 253971602
• Report Number: MW5101539
• Device Sequence Number: 1
• Product Code: EZW
• 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: 05/23/2021

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 68