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TPLC
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Device
stimulator, peripheral nerve, non-implanted, for urinary incontinence
Product Code
NAM
Regulation Number
876.5310
Device Class
2
Premarket Reviews
Manufacturer
Decision
ADVANCED URO-SOLUTIONS, INC.
SUBSTANTIALLY EQUIVALENT
1
AVATION MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
1. K220454
Vivally System Wearable, Non-Invasive Neuromodulat
...
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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