InjuryNAM
STIMGUARD INCONTINENCE STIMULATOR
Received Aug 12, 2023
Report MW5130928 · MDR key 17523980
Device
Generic name
Stimulator, Peripheral Nerve, Non-implanted, For Urinary Incontinence
Manufacturer
StimguardProduct problems
- Migration or Expulsion of Device
- Output Problem
- Migration or Expulsion of Device
- Output Problem
Patient
Unknown
- Pain
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Pain
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
THE PATIENT STATED THEY HAVE A DEVICE FOR BLADDER URGE INCONTINENCE AND ARE PART OF A STUDY. THE PATIENT STATED THEIR DOCTOR TOLD THEM PATIENT'S HAVE GOTTEN MRLS AND COMPLAINED OF PAIN, TINGLING OR MIGRATION OF THE IMPLANT SO THEY DON'T WANT THE PATIENT TO HAVE AN MRI. THE PATIENT NOTED THE DEVICE HADN'T BEEN WORKING LATELY. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).