TPLC - Total Product Life Cycle

• Device: permanent defibrillator electrodes
• Definition: Permanent defibrillator electrodes are used with compatible implantable cardioverter defibrillators (ICD) and cardiac rhythm therapy-defibrillators (CRT-D) to sense the cardiac rhythm and to deliver high energy therapy to the heart when tachycardia is detected. Some transvenous models can also be used for pacing the right ventricle.
• Product Code: NVY
• Device Class: 3

Premarket Approvals (PMA)
2007	2008	2009	2010	2011	2012	2013
12	27	30	82	89	92	30

Device Problems
High impedance	2294
Oversensing	1885
Dislodged or dislocated	1314
Device sensing issue	1283
No code available	1201
Failure to capture	1194
Inappropriate shock	1089
Low impedance	973
No Information	729
Break	727
Fracture	706
High capture threshold	620
Low sensing threshold	491
Failure to pace or properly pace	475
Material integrity issue	390
No Known Device Problem	348
Connection issue	196
Impedance issue	147
High sensing threshold	125
Undersensing	121
Failure to shock or properly shock	90
Device operates differently than expected	83
Device Issue	73
Device displays error message	72
Loose or intermittent connection	65
Noise	63
Aborted charge	55
Invalid sensing	54
Failure to sense	50
Difficult to position	48
Pocket stimulation	37
Use of Device Issue	36
Difficult to remove	33
Intermittent capture	29
Fitting problem	29
Failure to convert rhythm	27
Human-Device Interface Issue	20
Migration of device or device component	17
Failure to deploy	17
Electrical issue	16
Disinfection or Sterilization Issue at User Location	16
Sensing intermittently	15
Device damaged prior to use	15
Capturing issue	14
Difficult to insert	13
Loss of threshold	12
Device alarm system issue	12
Dislodged	11
No device output	10
Short fill	10
Retraction problem	9
Mechanical issue	7
Artifact	7
Output issue	5
Component(s), broken	5
Difficult to deploy	4
Normal	4
Lead(s), fracture of	4
Communication or transmission issue	3
Malfunction	3
Device Contamination with biological material	3
Device remains implanted	3
Incorrect measurement	2
Insulation degradation	2
Ambient noise issue	2
Explanted	2
No pacing	2
Low readings	2
Misconnection	2
Pacing inadequately	2
Unknown (for use when the device problem is not known)	1
Implant, repositioning of	1
Battery issue	1
Failure to advance	1
Bent	1
Degraded	1
Connection error	1
Installation-related problem	1
Bolus mechanism failure	1
Crack	1
Other (for use when an appropriate device code cannot be identified)	1
Unable to obtain readings	1
Arcing at electrodes	1
Detachment of device component	1
Application interface becomes non-functional or program exits abnormally	1
Device contamination with blood or blood product	1
Device, or device fragments remain in patient	1
Decreased sensitivity	1
Failure to interrogate	1
Radiofrequency interference (RFI)	1
Delayed charge time	1
Device abrasion from instrument or another object	1
Inappropriate or unexpected reset	1
Component missing	1
Expulsion	1
Performance	1
Alarm, error of warning	1
Electro-magnetic interference (EMI)	1
Incompatibility problem	1
Protective measure issue	1
Total Device Problems	17453