TPLC - Total Product Life Cycle

• Device: defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
• Definition: These devices will be indicated for patients needing an ICD who also have moderate to severe heart failure and are indicated for cardiac resynchronization therapy.
• Product Code: NIK
• Device Class: 3

Premarket Approvals (PMA)
2007	2008	2009	2010	2011	2012	2013
53	59	40	47	47	78	22

Device Problems
Low battery	3730
Premature discharge of battery	2179
High impedance	1581
Oversensing	1523
Premature elective replacement indicator	1404
Unknown (for use when the device problem is not known)	1332
Normal	1261
No code available	1260
Failure to pace or properly pace	1257
No Known Device Problem	1172
No Information	968
Failure to capture	710
Malfunction	704
Inappropriate shock	677
Noise	672
Device sensing issue	658
Device operates differently than expected	508
Device displays error message	422
Mechanical issue	418
Device remains activated	379
Connection issue	352
Dislodged or dislocated	315
Low impedance	304
Alarm, error of warning	285
High sensing threshold	247
Loose or intermittent connection	247
Undersensing	218
Device alarm system issue	208
Failure to shock or properly shock	197
Failure to interrogate	194
Communication or transmission issue	179
Connection error	179
Other (for use when an appropriate device code cannot be identified)	177
Loss of threshold	165
Defective item	163
Impedance issue	149
Artifact	130
Difficult to interrogate	128
Reset issue	126
Pocket stimulation	112
Failure to convert rhythm	101
Material integrity issue	100
Difficult to insert	93
Pacing inadequately	89
Pacer found in back-up mode	81
Power source issue	79
Data Issue	77
Failure to deliver	76
Dislodged	74
Use of Device Issue	68
Electro-magnetic interference (EMI)	66
Protective measure issue	64
Electrical issue	64
Migration of device or device component	62
Output above specifications	58
Delayed charge time	57
Interference	55
No device output	54
Material erosion	54
Device damaged prior to use	49
Performance	46
Shock counters, resetting of	46
Unexpected therapeutic results	46
Explanted	46
Telemetry discrepancy	44
Failure to sense	44
Unable to obtain readings	44
Incorrect measurement	41
False reading from device non-compliance	40
Device contamination with blood or blood product	40
Capturing issue	40
Sensitivity	39
Low readings	39
Premature end-of-life indicator	38
Device remains implanted	37
Difficult to Program or Calibrate	33
Out-of-box failure	32
Sensing intermittently	30
Inappropriate or unexpected reset	27
Installation-related problem	27
Device Issue	26
Product quality issue	26
Contamination during use	25
Implant, repositioning of	24
Battery issue	23
Output, high	23
Intermittent capture	23
Fitting problem	22
Invalid sensing	22
Misconnection	21
Failure to charge	18
Low audible alarm	18
Incorrect display	17
Output issue	15
Incorrect software programming calculations	15
Disinfection or Sterilization Issue at User Location	15
Fracture	14
Computer software issue	13
Programming issue	13
High capture threshold	12
Total Device Problems	29475

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	0	0	0
Class II	1	0	2	3	0	1	0
Class III	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific CRM Corp	II	May-08-2010
2	Boston Scientific CRM Corp	II	Jul-11-2007
3	Medtronic Inc. Cardiac Rhythm Disease Managment	II	Oct-21-2010
4	Medtronic Inc. Cardiac Rhythm Disease Managment	II	Nov-09-2009
5	Medtronic Inc. Cardiac Rhythm Managment	II	Jan-28-2009
6	St Jude Medical CRMD	II	May-03-2012
7	ela Medical Llc	II	Sep-27-2010