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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pulse generator, permanent, implantable
Definition Intended as a permanent implant to deliver pacing pulses and other pacing therapies through pacing leads implanted in the heart.
Product CodeNVZ
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
124 164 124 181 178 130 131 122 88 50

Device Problems
No code available 1644
Dislodged or dislocated 1544
Failure to capture 1285
Failure to pace or properly pace 1278
No Known Device Problem 1084
Premature discharge of battery 1041
Connection issue 760
No Information 711
High impedance 699
Device operates differently than expected 635
Oversensing 615
Failure to power-up 571
High sensing threshold 495
Device remains activated 461
Failure to interrogate 431
Device sensing issue 360
Mechanical issue 323
Communication or transmission issue 294
Undersensing 251
Low battery 240
Pacer found in back-up mode 234
Premature elective replacement indicator 231
Intermittent capture 215
Device displays error message 205
Failure to sense 201
Explanted 194
Device remains implanted 191
Reset issue 178
Ambient noise issue 176
Pacing inadequately 152
Impedance issue 149
High capture threshold 142
Difficult to interrogate 138
Connection error 129
Data Issue 129
Protective measure issue 129
Low impedance 123
Unable to obtain readings 123
No device output 114
Other (for use when an appropriate device code cannot be identified) 107
Incorrect display 106
Defective item 103
Artifact 98
Incorrect measurement 95
Fracture 92
Dislodged 91
Migration of device or device component 89
Electrical issue 88
Battery issue 83
Loose or intermittent connection 81
Pocket stimulation 81
Material integrity issue 79
Power source issue 71
Decreased sensitivity 70
Computer software issue 68
Electro-magnetic interference (EMI) 65
No pacing 64
No display or display failure 63
Failure to transmit record 62
Telemetry discrepancy 61
Pacing intermittently 60
Difficult to Program or Calibrate 59
Unknown (for use when the device problem is not known) 57
Use of Device Issue 55
Programming issue 55
Device contamination with blood or blood product 53
Out-of-box failure 52
Capturing issue 49
Inappropriate shock 49
Misconnection 48
Display misread 45
Incorrect or inadequate result 41
High battery impedance 41
Not Applicable 41
Break 38
Nonstandard device or device component 33
Incorrect or inadequate test results 33
Inadequate user interface 30
Premature end-of-life indicator 28
Sensing intermittently 27
Incorrect software programming calculations 25
Loss of Data 25
Battery impedance issue 25
Noise 22
Normal 20
Output above specifications 20
Output issue 20
Malfunction 17
Failure to deploy 17
Loss of power 16
Device inoperable 16
Device damaged prior to use 16
Component missing 15
Calibration issue 15
Failure to fire 14
Device or device component damaged by another device 14
Interference 14
Incorrect interpretation of rhythm 13
Sensitivity 13
Loss of threshold 12
Total Device Problems 20835

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 1 0 0 0 0 0 0 0
Class II 1 0 1 1 1 0 0 0 2 2
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc. Cardiac Rhythm Disease Management II Apr-29-2011
2 Medtronic Inc. Cardiac Rhythm Disease Managment II Aug-11-2010
3 Medtronic Inc. Cardiac Rhythm Disease Managment I Jun-11-2009
4 Medtronic Inc. Cardiac Rhythm Managment II Jul-07-2007
5 Medtronic Inc., Cardiac Rhythm and Heart Failure II Jul-05-2016
6 Medtronic Inc., Cardiac Rhythm and Heart Failure II May-04-2016
7 St Jude Medical Cardiac Rhythm Management Division II Sep-28-2015
8 St Jude Medical Cardiac Rhythm Management Division II Jan-09-2015
9 ela Medical Llc II Sep-24-2009

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