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TPLC
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show TPLC since
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Device
electrode, needle
Regulation Description
Needle electrode.
Product Code
GXZ
Regulation Number
882.1350
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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