TPLC - Total Product Life Cycle

• Device: stimulator, nerve, peripheral, electric
• Regulation Description: Electrical peripheral nerve stimulator.
• Product Code: KOI
• Regulation Number: 868.2775
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BLINK DEVICE COMPANY
	SUBSTANTIALLY EQUIVALENT	1
MIPM MAMMENDORFER INSTITUT FÜR PHYSIK UND MEDIZIN GMBH
	SUBSTANTIALLY EQUIVALENT	1
NERBIO MEDICAL SOFTWARE PLATFORMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
NIHON KOHDEN CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
SENZIME AB
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	4	4
2021	3	3
2022	4	4
2023	1	1
2024	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Use of Device Problem	3	3
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Excess Flow or Over-Infusion	2	2
Over-Sensing	2	2
Unexpected Therapeutic Results	2	2
Output Problem	1	1
Energy Output Problem	1	1
Insufficient Information	1	1
No Audible Alarm	1	1
Alarm Not Visible	1	1
Patient Device Interaction Problem	1	1
Thermal Decomposition of Device	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Device Handling Problem	1	1
Protective Measures Problem	1	1
Overheating of Device	1	1
No Device Output	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	4	4
No Code Available	2	2
No Clinical Signs, Symptoms or Conditions	2	2
Muscle Weakness	2	2
Oversedation	2	2
Skin Tears	2	2
Superficial (First Degree) Burn	1	1
Respiratory Acidosis	1	1
No Known Impact Or Consequence To Patient	1	1
Burn(s)	1	1
Paralysis	1	1
Pain	1	1