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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrode, needle
Regulation Description Needle electrode.
Product CodeGXZ
Regulation Number 882.1350
Device Class 2


Premarket Reviews
ManufacturerDecision
DAEHAN MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
RHYTHMLINK INTERNATIONAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
SPES MEDICA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 11 11
2017 6 6
2018 9 9
2019 14 14
2020 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Break 7 7
Failure to Sense 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Device Sensing Problem 5 5
Unable to Obtain Readings 4 4
Use of Device Problem 4 4
Material Separation 3 3
Device Operates Differently Than Expected 3 3
Needle 2 2
Detachment of Device or Device Component 2 2
Noise, Audible 2 2
Material Integrity Problem 2 2
Contamination 1 1
Difficult to Advance 1 1
Failure to Analyze Signal 1 1
Sensing Intermittently 1 1
Improper or Incorrect Procedure or Method 1 1
Low impedance 1 1
Defective Component 1 1
Electrode 1 1
Appropriate Term/Code Not Available 1 1
Defective Device 1 1
Component or Accessory Incompatibility 1 1
False Negative Result 1 1
Mechanical Problem 1 1
Unsealed Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 19 19
No Known Impact Or Consequence To Patient 10 10
Burn(s) 5 5
No Information 4 4
Needle Stick/Puncture 2 2
Foreign Body In Patient 1 1
Full thickness (Third Degree) Burn 1 1
Device Embedded In Tissue or Plaque 1 1
Cellulitis 1 1
Facial Nerve Paralysis 1 1
Unspecified Infection 1 1
Laceration(s) 1 1
Nerve Damage 1 1
Seizures 1 1
Injury 1 1
Fall 1 1
Lead(s), Burn(s) From 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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