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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 0

Device Problems
No Known Device Problem 1672
Device operates differently than expected 1472
High impedance 1318
Unknown (for use when the device problem is not known) 578
Inappropriate shock 551
Device remains implanted 530
Replace 461
Low impedance 437
Device displays error message 385
Break 362
No Information 358
Explanted 357
Migration of device or device component 324
Premature discharge of battery 319
Electro-magnetic interference (EMI) 304
Low battery 299
Failure to deliver energy 294
Other (for use when an appropriate device code cannot be identified) 263
Implant, reprogramming of 231
Battery issue 220
Intermittent continuity 211
Fracture 185
Communication or transmission issue 180
Bent 177
Malposition of device 161
Electromagnetic compatibility issue 158
Impedance issue 158
Unintended collision 150
Charging issue 145
Loss of power 122
Lead(s), breakage of 107
Device stops intermittently 101
Connection issue 93
Failure to interrogate 90
Wire(s), breakage of 80
Therapy delivered to incorrect body area 69
Unit inactivated 64
Implant, removal of 64
Electronic property issue 60
Device inoperable 60
Improper or incorrect procedure or method 60
Material deformation 57
Malfunction 50
Delayed charge time 50
Positioning Issue 49
Shipping damage or problem 49
Electro-magnetic interference (EMI), compatibility/incompatibility 48
Out-of-box failure 47
Kinked 44
Battery failure 44
Pocket stimulation 43
Unstable 40
Overheating of device or device component 38
Shock, electrical 37
Material erosion 37
Device or device fragments location unknown 36
Suspect EMI 36
Circuit breaker tripped 35
Device, or device fragments remain in patient 33
Device remains activated 32
No device output 31
Circuit Failure 31
Device Issue 31
Implant, repositioning of 31
Disconnection 30
Electrical shorting 28
Component(s), broken 25
Human-Device Interface Issue 24
Material integrity issue 24
No telemetry 23
Lead(s), fracture of 22
Difficult to Program or Calibrate 22
Tears, rips, holes in device, device material 21
Loose or intermittent connection 21
Foreign material present in device 20
Shelf life exceeded 19
Dislodged 18
Incorrect display 16
Unexpected therapeutic results 16
Misplacement 16
Dislodged or dislocated 16
Use of Device Issue 15
Hybrid failure 15
Electrode(s), fracture of 14
Fitting problem 14
Performance 14
Material twisted 14
Improper device output 13
Repair 13
Electrode contact(s), problem with 13
Loss of or failure to bond 13
Stretched 12
Device damaged prior to use 12
Difficult to position 12
Magnetic interference 12
Device or device component damaged by another device 12
No code available 11
Unintended movement 11
Peeled 11
Program, failure to 10
Total Device Problems 14761

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 0
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 Dec-03-2016
3 Medtronic Neuromodulation II Aug-24-2016
4 Medtronic Neuromodulation II Aug-19-2016
5 Medtronic Neuromodulation II May-15-2015
6 Medtronic Neuromodulation II Aug-18-2014
7 Medtronic Neuromodulation II Apr-29-2014
8 Medtronic Neuromodulation II Nov-14-2013
9 Medtronic Neuromodulation I May-01-2013
10 Medtronic Neuromodulation II Dec-19-2012
11 Medtronic Neuromodulation II Oct-27-2008
12 Medtronic Neuromodulation II Feb-05-2008
13 Medtronic Neuromodulation II Jun-15-2007

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