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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 50

Device Problems
No code available 1763
Failure to pace or properly pace 1691
Premature discharge of battery 1673
Dislodged or dislocated 1541
No Known Device Problem 1526
Failure to capture 1394
Oversensing 771
High impedance 768
Connection issue 767
No Information 727
Device operates differently than expected 691
Mechanical issue 630
Failure to interrogate 592
Failure to power-up 575
High sensing threshold 494
Device remains activated 462
Device sensing issue 405
Communication or transmission issue 320
Pacer found in back-up mode 313
Undersensing 293
Premature elective replacement indicator 276
Device displays error message 249
Low battery 241
Intermittent capture 227
Unable to obtain readings 224
Reset issue 219
Failure to sense 204
Battery issue 200
Explanted 195
Incorrect measurement 191
Device remains implanted 191
Ambient noise issue 187
High capture threshold 174
Impedance issue 172
Pacing inadequately 157
Migration of device or device component 145
Data Issue 143
Low impedance 141
Difficult to interrogate 139
Protective measure issue 136
Connection error 129
No device output 116
Artifact 110
Incorrect display 110
Other (for use when an appropriate device code cannot be identified) 107
Defective item 106
Electrical issue 106
Capturing issue 96
No pacing 95
Fracture 95
Use of Device Issue 93
Dislodged 91
Loose or intermittent connection 91
Pocket stimulation 85
Misconnection 83
Material integrity issue 82
Power source issue 78
Decreased sensitivity 75
Electro-magnetic interference (EMI) 74
High battery impedance 73
Computer software issue 70
Pacing intermittently 65
Failure to transmit record 65
No display or display failure 63
Telemetry discrepancy 62
Difficult to Program or Calibrate 60
Unknown (for use when the device problem is not known) 57
Device contamination with blood or blood product 57
Programming issue 56
Inappropriate shock 54
Out-of-box failure 52
Output issue 51
Inappropriate or unexpected reset 50
Display misread 45
Incorrect or inadequate result 43
Break 40
Not Applicable 40
Overheating of device or device component 39
Incorrect or inadequate test results 37
Battery impedance issue 37
Nonstandard device or device component 33
Premature end-of-life indicator 31
Inadequate user interface 30
Loss of Data 29
Sensing intermittently 28
Output above specifications 26
Incorrect software programming calculations 25
Invalid sensing 25
False positive result 24
Normal 22
Noise 22
Component missing 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
Calibration issue 15
Device expiration issue 15
Total Device Problems 24589

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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