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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, electrical, implanted, for parkinsonian tremor
Product CodeMHY
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
3 7 18 28 31 25 23 25 18 37 38

Device Problems
No Known Device Problem 2441
Device operates differently than expected 2218
High impedance 1708
Inappropriate shock 730
Device displays error message 656
Low impedance 652
Unknown (for use when the device problem is not known) 578
Failure to deliver energy 574
Break 553
Device remains implanted 530
Low battery 499
Replace 461
Premature discharge of battery 438
Battery issue 435
Migration of device or device component 409
Charging issue 382
Electro-magnetic interference (EMI) 369
No Information 358
Explanted 357
Communication or transmission issue 353
Intermittent continuity 302
Unintended collision 279
Electromagnetic compatibility issue 269
Other (for use when an appropriate device code cannot be identified) 263
Malposition of device 234
Implant, reprogramming of 231
Impedance issue 225
Bent 202
Fracture 187
Therapy delivered to incorrect body area 163
Failure to interrogate 156
Connection issue 147
Delayed charge time 128
Loss of power 122
Lead(s), breakage of 107
Device stops intermittently 101
Material deformation 97
Improper or incorrect procedure or method 96
Shipping damage or problem 84
Unstable 83
Wire(s), breakage of 80
Pocket stimulation 66
Device inoperable 65
Unit inactivated 64
Implant, removal of 64
Material integrity issue 63
Positioning Issue 62
Electronic property issue 60
Device or device fragments location unknown 58
Incorrect display 57
No device output 56
Overheating of device or device component 51
Malfunction 50
Electro-magnetic interference (EMI), compatibility/incompatibility 48
Out-of-box failure 47
Kinked 45
Battery failure 44
Material erosion 37
Shock, electrical 37
Disconnection 36
Suspect EMI 36
Foreign material present in device 36
Circuit breaker tripped 35
Device, or device fragments remain in patient 33
Device remains activated 32
Circuit Failure 31
Implant, repositioning of 31
Device Issue 31
Electrical shorting 28
Difficult to Program or Calibrate 28
Shelf life exceeded 27
Human-Device Interface Issue 26
Component(s), broken 25
Unexpected therapeutic results 24
Use of Device Issue 23
No telemetry 23
Lead(s), fracture of 22
Loose or intermittent connection 21
Tears, rips, holes in device, device material 21
Energy output to patient tissue incorrect 21
Environmental control or utility issue 20
Improper device output 20
Material twisted 19
Loss of Data 19
Dislodged 18
Misplacement 16
Dislodged or dislocated 16
No code available 15
Stretched 15
Hybrid failure 15
Electrode(s), fracture of 14
Incorrect or inadequate result 14
Performance 14
Device or device component damaged by another device 14
Fitting problem 14
Component missing 13
Premature elective replacement indicator 13
Peeled 13
Failure to power-up 13
Repair 13
Total Device Problems 20129

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 1 0 0 0 0
Class II 1 2 0 0 0 1 2 2 1 3 3
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Neuromodulation Systems Inc. II Feb-28-2013
2 Medtronic Neuromodulation II Aug-23-2017
3 Medtronic Neuromodulation II Dec-03-2016
4 Medtronic Neuromodulation II Aug-24-2016
5 Medtronic Neuromodulation II Aug-19-2016
6 Medtronic Neuromodulation II May-15-2015
7 Medtronic Neuromodulation II Aug-18-2014
8 Medtronic Neuromodulation II Apr-29-2014
9 Medtronic Neuromodulation II Nov-14-2013
10 Medtronic Neuromodulation I May-01-2013
11 Medtronic Neuromodulation II Dec-19-2012
12 Medtronic Neuromodulation II Oct-27-2008
13 Medtronic Neuromodulation II Feb-05-2008
14 Medtronic Neuromodulation II Jun-15-2007
15 St. Jude Medical, Inc. II Oct-17-2017
16 St. Jude Medical, Inc. II Jul-07-2017

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