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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 41

Device Problems
No code available 1611
Dislodged or dislocated 1542
Failure to capture 1269
Failure to pace or properly pace 1211
No Known Device Problem 1041
Premature discharge of battery 950
Connection issue 759
No Information 706
High impedance 684
Device operates differently than expected 632
Oversensing 593
Failure to power-up 571
High sensing threshold 495
Device remains activated 461
Failure to interrogate 418
Device sensing issue 355
Communication or transmission issue 291
Mechanical issue 288
Undersensing 244
Low battery 239
Pacer found in back-up mode 224
Premature elective replacement indicator 223
Intermittent capture 214
Failure to sense 200
Device displays error message 196
Explanted 194
Device remains implanted 191
Ambient noise issue 175
Reset issue 173
Pacing inadequately 152
Impedance issue 143
Difficult to interrogate 137
High capture threshold 135
Protective measure issue 129
Connection error 129
Data Issue 125
Low impedance 121
No device output 114
Unable to obtain readings 111
Other (for use when an appropriate device code cannot be identified) 107
Incorrect display 106
Defective item 103
Artifact 98
Fracture 92
Dislodged 91
Incorrect measurement 88
Electrical issue 86
Pocket stimulation 81
Loose or intermittent connection 79
Material integrity issue 79
Migration of device or device component 77
Power source issue 70
Decreased sensitivity 70
Computer software issue 68
Battery issue 67
Electro-magnetic interference (EMI) 65
No display or display failure 63
Telemetry discrepancy 61
Failure to transmit record 61
No pacing 61
Difficult to Program or Calibrate 59
Pacing intermittently 59
Unknown (for use when the device problem is not known) 57
Programming issue 55
Use of Device Issue 54
Out-of-box failure 52
Device contamination with blood or blood product 51
Inappropriate shock 48
Misconnection 48
Display misread 45
Capturing issue 45
Not Applicable 41
Incorrect or inadequate result 41
High battery impedance 39
Break 38
Nonstandard device or device component 33
Incorrect or inadequate test results 32
Inadequate user interface 30
Sensing intermittently 27
Premature end-of-life indicator 26
Incorrect software programming calculations 25
Loss of Data 24
Noise 22
Normal 20
Battery impedance issue 20
Output above specifications 19
Failure to deploy 17
Malfunction 17
Device damaged prior to use 16
Loss of power 16
Device inoperable 16
Component missing 15
Calibration issue 15
Device or device component damaged by another device 15
Output issue 15
Failure to fire 14
Interference 14
Incorrect interpretation of rhythm 13
Sensitivity 13
Loss of threshold 12
Total Device Problems 20337

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 1
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 May-04-2016
6 St Jude Medical Cardiac Rhythm Management Division II Sep-28-2015
7 St Jude Medical Cardiac Rhythm Management Division II Jan-09-2015
8 ela Medical Llc II Sep-24-2009

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