TPLC - Total Product Life Cycle

• Device: electrode, depth
• Regulation Description: Depth electrode.
• Product Code: GZL
• Regulation Number: 882.1330
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AD-TECH MEDICAL INSTRUMENT CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
ALPHA OMEGA ENGINEERING , LTD.
	SUBSTANTIALLY EQUIVALENT	2
BEIJING SINOVATION MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DIXI MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
ICE NEUROSYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
NEUROONE MEDICAL TECHNOLOGIES CORP.
	SUBSTANTIALLY EQUIVALENT	2
SENSOMEDICAL LABS, LTD.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2021	13	13
2022	10	10
2023	30	30
2024	16	16
2025	12	12
2026	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	11	11
Material Integrity Problem	6	6
Material Fragmentation	6	6
Material Separation	6	6
Signal Artifact/Noise	5	5
Fracture	5	5
Break	3	3
Insufficient Information	3	3
Defective Component	3	3
Appropriate Term/Code Not Available	3	3
Disconnection	2	2
Energy Output Problem	2	2
Defective Device	2	2
Difficult to Remove	2	2
Separation Problem	1	1
Entrapment of Device	1	1
Mechanical Problem	1	1
Malposition of Device	1	1
Communication or Transmission Problem	1	1
Output Problem	1	1
Image Display Error/Artifact	1	1
Peeled/Delaminated	1	1
Separation Failure	1	1
Positioning Problem	1	1
Impedance Problem	1	1
Positioning Failure	1	1
Failure to Power Up	1	1
Use of Device Problem	1	1
Material Twisted/Bent	1	1
Structural Problem	1	1
Device Damaged by Another Device	1	1
Electromagnetic Compatibility Problem	1	1
Detachment of Device or Device Component	1	1
No Apparent Adverse Event	1	1
Missing Information	1	1
Inadequate or Insufficient Training	1	1
Loss of or Failure to Bond	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Foreign Body In Patient	30	30
No Clinical Signs, Symptoms or Conditions	28	28
Insufficient Information	10	10
Intracranial Hemorrhage	4	4
Cramp(s) /Muscle Spasm(s)	2	2
Paresthesia	2	2
Paralysis	2	2
Unspecified Infection	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Stroke/CVA	1	1
Fatigue	1	1
Brain Injury	1	1
Fungal Infection	1	1
Dizziness	1	1
Hematoma	1	1
Purulent Discharge	1	1
Visual Disturbances	1	1
Laceration(s)	1	1
Shaking/Tremors	1	1
Convulsion/Seizure	1	1
Hemorrhage/Bleeding	1	1
Cancer	1	1
Low Blood Pressure/ Hypotension	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Ad-Tech Medical Instrument Corporation	II	Oct-24-2024
2	DIXI MEDICAL USA	II	Jan-28-2022