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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, peripheral nerve, non-implanted, for urinary incontinence
Product CodeNAM
Regulation Number 876.5310
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED URO-SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AVATION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXODUS INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
UROPLASTY, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 26 26
2017 52 52
2018 4 4
2019 2 2
2021 2 2
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 77 77
Device Operates Differently Than Expected 4 4
Failure to Deliver Energy 2 2
Migration or Expulsion of Device 1 1
Loss of Power 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Patient-Device Incompatibility 1 1
Output Problem 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Urinary Tract Infection 44 44
Complaint, Ill-Defined 18 18
Incontinence 17 17
Urinary Retention 16 16
Pain 12 12
Unspecified Infection 12 12
Therapeutic Effects, Unexpected 11 11
Therapeutic Response, Decreased 9 9
Urinary Frequency 8 8
Micturition Urgency 8 8
Bacterial Infection 6 6
Malaise 6 6
No Known Impact Or Consequence To Patient 5 5
Swelling 5 5
Muscle Spasm(s) 4 4
Ambulation Difficulties 4 4
Discomfort 3 3
Hemorrhage/Bleeding 3 3
Diarrhea 3 3
Fall 2 2
Dehydration 2 2
Bone Fracture(s) 2 2
Itching Sensation 2 2
Burning Sensation 2 2
Tingling 2 2
Respiratory Tract Infection 2 2
Obstruction/Occlusion 2 2
Sleep Dysfunction 2 2
Dysuria 2 2
Shaking/Tremors 1 1
Cognitive Changes 1 1
Hematuria 1 1
Weight Changes 1 1
Chills 1 1
Fasciitis 1 1
Numbness 1 1
Loss of consciousness 1 1
Fungal Infection 1 1
Convulsion/Seizure 1 1
Urinary Incontinence 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Weakness 1 1
Tachycardia 1 1
Thrombosis 1 1
Low Blood Pressure/ Hypotension 1 1
Respiratory Distress 1 1
Muscular Rigidity 1 1
Myocardial Infarction 1 1
Undesired Nerve Stimulation 1 1
Neuropathy 1 1
Fatigue 1 1
Inflammation 1 1
Irritation 1 1
Edema 1 1
Rheumatoid Arthritis 1 1
Asthma 1 1
Atrial Fibrillation 1 1
Bronchitis 1 1
Chest Pain 1 1
Connective Tissue Disease 1 1
Cyanosis 1 1

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