TPLC - Total Product Life Cycle

• Device: drug eluting permanent left ventricular (lv) pacemaker electrode
• Definition: Drug eluting permanent lv pacemaker electrodes are used with compatible cardiac rhythm therapy (crt) devices to deliver pacing pulses to the heart.
• Product Code: OJX
• Device Class: 3

Premarket Approvals (PMA)
2007	2008	2009	2010	2011	2012	2013
1	1	9	41	63	52	23

Device Problems
Dislodged or dislocated	1607
Failure to capture	1076
No code available	889
High impedance	700
Difficult to position	483
No Information	440
Fracture	357
Patient-device incompatibility	333
Pocket stimulation	301
No Known Device Problem	229
High sensing threshold	148
Capturing issue	137
Device sensing issue	114
Material integrity issue	113
High capture threshold	84
Failure to pace or properly pace	79
Device remains activated	78
Difficult to insert	72
Oversensing	66
Low impedance	52
Device contamination with blood or blood product	38
Size incorrect for patient	37
Device operates differently than expected	36
Impedance issue	32
Difficult to remove	26
Failure to sense	25
Use of Device Issue	25
Connection issue	24
Migration of device or device component	24
Other (for use when an appropriate device code cannot be identified)	22
Device damaged prior to use	21
Dislodged	20
Intermittent capture	18
Mechanical issue	18
Device expiration issue	17
Failure to advance	16
Hole in material	13
Installation-related problem	13
Degraded	13
Defective item	12
Normal	11
Break	10
Electrical issue	10
Device Contamination with biological material	9
Loss of threshold	7
Positioning Issue	7
Disinfection or Sterilization Issue at User Location	7
Explanted	7
Component(s), broken	6
Cut in material	6
Difficult to deploy	6
Loose or intermittent connection	6
Human-Device Interface Issue	6
Device inoperable	5
Inappropriate shock	5
Premature discharge of battery	5
Retraction problem	5
No pacing	4
Undersensing	4
Failure to deploy	4
Material separation	4
Communication or transmission issue	3
Device remains implanted	3
Sensing intermittently	3
Reset issue	3
Unstable	3
Device alarm system issue	3
Difficult to advance	3
Kinked	3
Artifact	3
Obstruction within device	3
Shelf life exceeded	3
Output issue	3
Unknown (for use when the device problem is not known)	2
Stretched	2
Material perforation	2
Implant, reprogramming of	2
Fluid leak	2
Lead(s), fracture of	2
Detachment of device or device component	2
Failure to shock or properly shock	2
Difficult to Program or Calibrate	2
Fitting problem	2
Foreign material present in device	2
Performance	2
Device-device incompatibility	2
Device or device component damaged by another device	2
Device, or device fragments remain in patient	1
Electro-magnetic interference (EMI)	1
High battery impedance	1
Noise	1
Uncoiled	1
Sensitivity	1
Bent	1
False alarm	1
Sticking	1
Material deformation	1
Corrosion	1
Power source issue	1
Contamination during use	1
Total Device Problems	8019