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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 70

Device Problems
No code available 1678
Dislodged or dislocated 1553
Failure to pace or properly pace 1407
Failure to capture 1316
Premature discharge of battery 1214
No Known Device Problem 1178
Connection issue 764
No Information 722
High impedance 720
Oversensing 665
Device operates differently than expected 648
Failure to power-up 571
High sensing threshold 495
Failure to interrogate 481
Device remains activated 462
Mechanical issue 395
Device sensing issue 374
Communication or transmission issue 301
Undersensing 263
Pacer found in back-up mode 257
Premature elective replacement indicator 249
Low battery 240
Intermittent capture 219
Device displays error message 215
Failure to sense 202
Explanted 195
Device remains implanted 191
Reset issue 187
Ambient noise issue 184
Pacing inadequately 154
High capture threshold 153
Impedance issue 152
Unable to obtain readings 143
Difficult to interrogate 139
Data Issue 132
Protective measure issue 132
Connection error 129
Low impedance 126
No device output 114
Incorrect measurement 113
Battery issue 110
Other (for use when an appropriate device code cannot be identified) 107
Migration of device or device component 107
Incorrect display 106
Defective item 103
Artifact 100
Fracture 94
Electrical issue 93
Dislodged 91
Loose or intermittent connection 84
Pocket stimulation 81
Material integrity issue 80
Use of Device Issue 77
No pacing 75
Power source issue 73
Decreased sensitivity 70
Computer software issue 68
Electro-magnetic interference (EMI) 66
Failure to transmit record 64
No display or display failure 63
Pacing intermittently 61
Telemetry discrepancy 61
Difficult to Program or Calibrate 60
Capturing issue 60
Unknown (for use when the device problem is not known) 57
Misconnection 56
Device contamination with blood or blood product 56
Programming issue 55
Out-of-box failure 52
Inappropriate shock 49
Display misread 45
High battery impedance 44
Not Applicable 41
Incorrect or inadequate result 41
Break 39
Incorrect or inadequate test results 34
Nonstandard device or device component 33
Premature end-of-life indicator 30
Output issue 30
Inadequate user interface 30
Battery impedance issue 29
Loss of Data 27
Sensing intermittently 27
Incorrect software programming calculations 25
Normal 22
Output above specifications 22
Noise 22
Inappropriate or unexpected reset 21
Invalid sensing 18
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
Overheating of device or device component 15
Interference 14
Failure to fire 14
Total Device Problems 21866

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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