TPLC - Total Product Life Cycle

• 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