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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 5

Device Problems
No Known Device Problem 1821
Device operates differently than expected 1635
High impedance 1398
Inappropriate shock 593
Unknown (for use when the device problem is not known) 578
Device remains implanted 530
Low impedance 483
Replace 461
Device displays error message 449
Break 388
No Information 358
Explanted 357
Premature discharge of battery 351
Failure to deliver energy 349
Low battery 346
Migration of device or device component 340
Electro-magnetic interference (EMI) 313
Other (for use when an appropriate device code cannot be identified) 263
Battery issue 262
Implant, reprogramming of 231
Intermittent continuity 227
Communication or transmission issue 208
Charging issue 203
Fracture 185
Bent 181
Malposition of device 176
Electromagnetic compatibility issue 175
Unintended collision 175
Impedance issue 167
Loss of power 122
Lead(s), breakage of 107
Connection issue 105
Device stops intermittently 101
Failure to interrogate 100
Therapy delivered to incorrect body area 87
Wire(s), breakage of 80
Delayed charge time 74
Improper or incorrect procedure or method 67
Unit inactivated 64
Implant, removal of 64
Material deformation 64
Electronic property issue 60
Device inoperable 60
Shipping damage or problem 53
Positioning Issue 52
Malfunction 50
Electro-magnetic interference (EMI), compatibility/incompatibility 48
Unstable 48
Pocket stimulation 48
Out-of-box failure 47
Kinked 44
Battery failure 44
Device or device fragments location unknown 42
Overheating of device or device component 41
Shock, electrical 37
Material erosion 37
Suspect EMI 36
Circuit breaker tripped 35
No device output 33
Device, or device fragments remain in patient 33
Device remains activated 32
Material integrity issue 32
Device Issue 31
Implant, repositioning of 31
Circuit Failure 31
Disconnection 31
Electrical shorting 28
Foreign material present in device 25
Component(s), broken 25
Human-Device Interface Issue 24
No telemetry 23
Incorrect display 22
Lead(s), fracture of 22
Difficult to Program or Calibrate 22
Tears, rips, holes in device, device material 21
Shelf life exceeded 21
Loose or intermittent connection 21
Unexpected therapeutic results 19
Dislodged 18
Use of Device Issue 17
Misplacement 16
Dislodged or dislocated 16
Hybrid failure 15
Electrode(s), fracture of 14
Performance 14
Fitting problem 14
Material twisted 14
Improper device output 13
Stretched 13
Repair 13
Electrode contact(s), problem with 13
Loss of or failure to bond 13
Device damaged prior to use 12
Peeled 12
Difficult to position 12
Magnetic interference 12
Device or device component damaged by another device 12
No code available 11
Unintended movement 11
Energy output to patient tissue incorrect 11
Total Device Problems 15843

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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