TPLC - Total Product Life Cycle

• Device: pacemaker lead adaptor
• Regulation Description: Pacemaker lead adaptor.
• Product Code: DTD
• Regulation Number: 870.3620
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BIOTRONIK GMBG & CO.
	SE SUBJECT TO TRACKING REG	1
	SE SUBJECT TO TRAKING & PMS	2
	SUBSTANTIALLY EQUIVALENT	3
CORDIS CORP.
	SUBSTANTIALLY EQUIVALENT	3
GUIDANT CORP
	SUBSTANTIALLY EQUIVALENT	6
INTERMEDICS
	SUBSTANTIALLY EQUIVALENT	14
MEDTRONIC, INC.
	SE SUBJECT TO TRACKING REG	2
	SUBSTANTIALLY EQUIVALENT	18
OSCOR, INC.
	SE SUBJECT TO TRACKING REG	1
	SUBSTANTIALLY EQUIVALENT	2
POSSIS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS
	SUBSTANTIALLY EQUIVALENT	1
ST. JUDE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	4
TELECTRONICS
	SUBSTANTIALLY EQUIVALENT	5

Device Problems
No code available	16
High impedance	10
Fitting problem	4
Fracture	4
No Information	3
Unknown (for use when the device problem is not known)	3
Defective item	3
No Known Device Problem	3
Failure to capture	3
Device remains activated	2
Connection issue	2
Device sensing issue	2
Impedance issue	2
Low impedance	2
Failure to disconnect	2
High sensing threshold	1
Adaptor, failure of	1
Break	1
Structural problem	1
Material integrity issue	1
Output issue	1
Device displays error message	1
Capturing issue	1
Failure to sense	1
Sensitivity	1
Inappropriate shock	1
Use of Device Issue	1
Component(s), broken	1
Elective replacement	1
Device expiration issue	1
Insulation, hole(s) in	1
Mechanical issue	1
Misapplication	1
Normal	1
Oversensing	1
Performance	1
User used incorrect product for intended use	1
Total Device Problems	83