TPLC - Total Product Life Cycle

• Device: implantable pacemaker pulse-generator
• Regulation Description: Implantable pacemaker pulse generator.
• Product Code: DXY
• Regulation Number: 870.3610
• Device Class: 3

Premarket Reviews
Manufacturer	Decision
BENTLEY LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	4
BIOTRONIK GMBG & CO.
	SE SUBJECT TO TRACKING REG	1
	SUBSTANTIALLY EQUIVALENT	6
	SUBSTANTIALLY EQUIVALENT - POSTMARKET SURVEILLANCE	2
CORDIS CORP.
	SUBSTANTIALLY EQUIVALENT	21
ELA MEDICAL, INC.
	SE SUBJECT TO TRACKING REG	2
	SUBSTANTIALLY EQUIVALENT	20
GUIDANT CORP
	SUBSTANTIALLY EQUIVALENT	37
INTERMEDICS
	SUBSTANTIALLY EQUIVALENT	52
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SE SUBJECT TO TRACKING REG	4
	SUBSTANTIALLY EQUIVALENT	55
	SUBSTANTIALLY EQUIVALENT - POSTMARKET SURVEILLANCE	1
PACE MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	2
SHILEY, INC
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS
	SUBSTANTIALLY EQUIVALENT	15
TELECTRONICS
	SUBSTANTIALLY EQUIVALENT	3

Device Problems
Premature discharge of battery	2942
Low battery	2683
Failure to pace or properly pace	1832
Failure to interrogate	1508
Unknown (for use when the device problem is not known)	1393
Failure to capture	1166
Difficult to interrogate	1154
No device output	1087
No code available	817
Oversensing	738
Normal	729
High impedance	710
Premature elective replacement indicator	647
Device remains activated	643
Reset issue	582
Device displays error message	543
No Known Device Problem	527
Incorrect measurement	509
Other (for use when an appropriate device code cannot be identified)	501
Malfunction	498
Pacer found in back-up mode	491
High battery impedance	462
Noise	424
Explanted	391
Pacing inadequately	374
Mechanical issue	324
Telemetry discrepancy	318
Magnet mode discrepancy	313
Power source issue	299
Connection error	276
Program, failure to	218
No Information	214
Communication or transmission issue	208
High sensing threshold	179
Measurements, inaccurate	173
Unable to obtain readings	168
Computer software issue	167
Loss of threshold	166
Undersensing	160
Defective item	157
Device damaged prior to use	150
Failure to sense	149
Failure to power-up	139
No display or display failure	136
Alarm, error of warning	134
Electro-magnetic interference (EMI)	130
Intermittent capture	129
Shock counters, resetting of	125
Connection issue	125
Device remains implanted	118
Performance	117
Artifact	115
Premature end-of-life indicator	112
Sensing intermittently	108
Device sensing issue	105
Elective replacement	102
Low impedance	101
Pacing intermittently	91
Failure to deliver	89
Loose or intermittent connection	86
Pocket stimulation	78
False reading from device non-compliance	78
Impedance issue	73
Sensitivity	69
Data Issue	68
Electrical issue	67
Device Issue	61
No pacing	60
Output issue	54
Difficult to Program or Calibrate	52
Device inoperable	51
Power calculation error due to software problem	50
Implant, reprogramming of	48
Out-of-box failure	48
Crack	47
Device operates differently than expected	45
Product quality issue	45
Invalid sensing	42
Break	42
Loss of power	39
Contamination during use	39
Material erosion	38
Inappropriate shock	36
Low readings	36
Capturing issue	35
Incorrect display	33
Device contamination with blood or blood product	30
Failure to fire	28
Dislodged	27
Lead(s), fracture of	27
Migration of device or device component	25
Output above specifications	23
Interference	21
Dislodged or dislocated	20
Use of Device Issue	19
Programming issue	19
Battery issue	19
Overheating of device or device component	17
Incorrect software programming calculations	16
Material integrity issue	16
Total Device Problems	30693

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	1	0	0	0	0
Class II	0	0	0	1	0	1	0
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Inc. Cardiac Rhythm Disease Managment	II	Apr-26-2010
2	Medtronic Inc. Cardiac Rhythm Disease Managment	I	Jun-11-2009
3	St Jude Medical CRMD	II	Jan-11-2012