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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
AVATION MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
EXODUS INNOVATIONS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
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
2
2
Output Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Migration or Expulsion of Device
1
1
Loss of Power
1
1
Inappropriate/Inadequate Shock/Stimulation
1
1
Patient-Device Incompatibility
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Cyanosis
1
1
Dehydration
1
1
Undesired Nerve Stimulation
1
1
Pain
1
1
Swelling
1
1
Urinary Retention
1
1
Therapeutic Response, Decreased
1
1
Malaise
1
1
Loss of consciousness
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
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