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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 59

Device Problems
No code available 1664
Dislodged or dislocated 1545
Failure to pace or properly pace 1333
Failure to capture 1297
No Known Device Problem 1128
Premature discharge of battery 1117
Connection issue 762
No Information 714
High impedance 705
Device operates differently than expected 638
Oversensing 637
Failure to power-up 571
High sensing threshold 495
Device remains activated 461
Failure to interrogate 454
Mechanical issue 364
Device sensing issue 364
Communication or transmission issue 297
Undersensing 258
Pacer found in back-up mode 240
Low battery 240
Premature elective replacement indicator 235
Intermittent capture 217
Device displays error message 209
Failure to sense 201
Explanted 194
Device remains implanted 191
Reset issue 185
Ambient noise issue 176
Pacing inadequately 153
Impedance issue 151
High capture threshold 146
Difficult to interrogate 138
Unable to obtain readings 132
Data Issue 131
Protective measure issue 131
Connection error 129
Low impedance 124
No device output 114
Other (for use when an appropriate device code cannot be identified) 107
Incorrect display 106
Defective item 103
Incorrect measurement 102
Battery issue 101
Artifact 99
Migration of device or device component 95
Fracture 92
Dislodged 91
Electrical issue 90
Loose or intermittent connection 83
Pocket stimulation 81
Material integrity issue 79
No pacing 73
Power source issue 71
Decreased sensitivity 70
Computer software issue 68
Electro-magnetic interference (EMI) 66
No display or display failure 63
Failure to transmit record 63
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 56
Device contamination with blood or blood product 55
Programming issue 55
Out-of-box failure 52
Capturing issue 52
Misconnection 51
Inappropriate shock 49
Display misread 45
High battery impedance 43
Not Applicable 41
Incorrect or inadequate result 41
Break 38
Nonstandard device or device component 33
Incorrect or inadequate test results 33
Inadequate user interface 30
Battery impedance issue 28
Premature end-of-life indicator 28
Sensing intermittently 27
Incorrect software programming calculations 25
Loss of Data 25
Output issue 25
Noise 22
Normal 20
Output above specifications 20
Inappropriate or unexpected reset 18
Device or device component damaged by another device 17
Malfunction 17
Failure to deploy 17
Loss of power 16
Device damaged prior to use 16
Device inoperable 16
Component missing 15
Calibration issue 15
Failure to fire 14
Invalid sensing 14
Interference 14
Incorrect interpretation of rhythm 13
Total Device Problems 21277

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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