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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 2017
124 164 124 181 178 130 131 122 88 76 4

Device Problems
No code available 1686
Dislodged or dislocated 1553
Failure to pace or properly pace 1450
Failure to capture 1335
Premature discharge of battery 1282
No Known Device Problem 1237
Connection issue 764
High impedance 730
No Information 726
Oversensing 688
Device operates differently than expected 659
Failure to power-up 571
Failure to interrogate 502
High sensing threshold 495
Device remains activated 462
Mechanical issue 429
Device sensing issue 377
Communication or transmission issue 304
Pacer found in back-up mode 274
Undersensing 270
Premature elective replacement indicator 264
Low battery 240
Device displays error message 228
Intermittent capture 220
Failure to sense 203
Explanted 195
Reset issue 193
Device remains implanted 191
Ambient noise issue 185
High capture threshold 159
Unable to obtain readings 154
Pacing inadequately 154
Impedance issue 153
Difficult to interrogate 139
Data Issue 134
Protective measure issue 133
Incorrect measurement 133
Low impedance 131
Connection error 129
Battery issue 124
No device output 116
Migration of device or device component 110
Incorrect display 108
Other (for use when an appropriate device code cannot be identified) 107
Defective item 103
Artifact 101
Electrical issue 96
Fracture 94
Dislodged 91
Loose or intermittent connection 85
No pacing 82
Material integrity issue 81
Pocket stimulation 81
Use of Device Issue 80
Power source issue 73
Decreased sensitivity 71
Computer software issue 70
Electro-magnetic interference (EMI) 67
Failure to transmit record 65
Capturing issue 65
No display or display failure 63
Pacing intermittently 62
Telemetry discrepancy 61
Misconnection 61
Difficult to Program or Calibrate 60
Unknown (for use when the device problem is not known) 57
Device contamination with blood or blood product 56
Programming issue 55
Out-of-box failure 52
Inappropriate shock 52
High battery impedance 48
Display misread 45
Incorrect or inadequate result 41
Not Applicable 41
Break 40
Incorrect or inadequate test results 35
Output issue 33
Nonstandard device or device component 33
Battery impedance issue 31
Inadequate user interface 30
Premature end-of-life indicator 30
Loss of Data 28
Sensing intermittently 27
Incorrect software programming calculations 25
Output above specifications 24
Inappropriate or unexpected reset 23
Noise 22
Normal 22
Overheating of device or device component 19
Invalid sensing 19
Device or device component damaged by another device 18
Malfunction 17
Failure to deploy 17
Loss of power 16
Device inoperable 16
Device damaged prior to use 16
Component missing 16
Calibration issue 15
Failure to fire 14
Interference 14
Total Device Problems 22356

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 1 0 0 0 0 0 0 0 0
Class II 1 0 1 1 1 0 0 0 2 2 0
Class III 0 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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