TPLC - Total Product Life Cycle

• Device: programmer, pacemaker
• Regulation Description: Pacemaker programmers.
• Product Code: KRG
• Regulation Number: 870.3700
• Device Class: 3

Premarket Reviews
Manufacturer	Decision
CORDIS CORP.
	SUBSTANTIALLY EQUIVALENT	3
GUIDANT CORP
	SUBSTANTIALLY EQUIVALENT	7
INTERMEDICS
	SUBSTANTIALLY EQUIVALENT	4
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	1

Premarket Approvals (PMA)
2007	2008	2009	2010	2011	2012	2013
1	0	0	0	0	0	1

Device Problems
Electrical issue	434
Device displays error message	299
Failure to interrogate	200
No code available	194
Mechanical issue	171
Computer software issue	69
Communication or transmission issue	40
No Information	36
No display or display failure	36
Difficult to interrogate	33
Break	25
Device inoperable	20
Component missing	18
Incorrect display	16
Failure to power-up	16
Device operates differently than expected	15
Defective item	11
Artifact	10
Improper or incorrect procedure or method	8
Implant, reprogramming of	7
Material integrity issue	7
No Known Device Problem	7
Connection issue	7
Failure to capture	6
Loss of power	6
Overheating of device or device component	5
Loose or intermittent connection	5
Output issue	5
Telemetry discrepancy	4
Device or device component damaged by another device	4
Bent	4
Crack	4
Application interface becomes non-functional or program exits abnormally	4
Degraded	4
Detachment of device component	3
Electro-magnetic interference (EMI)	3
Incorrect software programming calculations	3
Device stops intermittently	3
Power source issue	3
Not Applicable	3
Data Issue	3
Noise, Audible	3
Programming issue	2
Unknown (for use when the device problem is not known)	2
Difficult to Program or Calibrate	2
Radio signal problem	2
Unable to obtain readings	2
Failure to transmit record	2
Device remains activated	2
Incorrect measurement	2
Kinked	2
Material frayed	2
Interference	1
Corrosion	1
Display misread	1
Moisture damage	1
Failure to pace or properly pace	1
Device remains implanted	1
Inappropriate shock	1
Product quality issue	1
Failure to prime	1
Computer operating system issue	1
Device sensing issue	1
Human-Device Interface Issue	1
Inadequate user interface	1
Issue with displayed error message	1
Use of Device Issue	1
Failure to disconnect	1
Noise	1
Other (for use when an appropriate device code cannot be identified)	1
Problem with software installation	1
Operating system version or upgrade problem	1
Mechanical jam	1
Total Device Problems	1795

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	0	0	0	2	0	0	0
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific CRM Corp	II	Oct-07-2010
2	Boston Scientific CRM Corp	II	May-08-2010