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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
3 7 18 28 31 25 23 25 18 30

Device Problems
No Known Device Problem 1510
Device operates differently than expected 1317
High impedance 1250
Unknown (for use when the device problem is not known) 578
Inappropriate shock 530
Device remains implanted 530
Replace 461
Low impedance 402
No Information 358
Explanted 357
Device displays error message 327
Break 325
Migration of device or device component 311
Electro-magnetic interference (EMI) 301
Premature discharge of battery 279
Other (for use when an appropriate device code cannot be identified) 263
Low battery 260
Failure to deliver energy 248
Implant, reprogramming of 231
Intermittent continuity 199
Battery issue 192
Fracture 185
Bent 170
Communication or transmission issue 157
Malposition of device 143
Impedance issue 142
Electromagnetic compatibility issue 140
Unintended collision 126
Charging issue 123
Loss of power 122
Lead(s), breakage of 107
Device stops intermittently 101
Connection issue 84
Wire(s), breakage of 80
Failure to interrogate 78
Unit inactivated 64
Implant, removal of 64
Therapy delivered to incorrect body area 62
Device inoperable 60
Electronic property issue 60
Improper or incorrect procedure or method 53
Malfunction 50
Positioning Issue 49
Electro-magnetic interference (EMI), compatibility/incompatibility 48
Out-of-box failure 47
Material deformation 46
Kinked 44
Battery failure 44
Delayed charge time 40
Pocket stimulation 39
Shock, electrical 37
Material erosion 37
Shipping damage or problem 36
Suspect EMI 36
Circuit breaker tripped 35
Device or device fragments location unknown 34
Unstable 33
Device, or device fragments remain in patient 33
Overheating of device or device component 33
Device remains activated 32
Circuit Failure 31
Device Issue 31
Implant, repositioning of 31
Electrical shorting 28
Disconnection 28
No device output 26
Component(s), broken 25
Human-Device Interface Issue 23
No telemetry 23
Lead(s), fracture of 22
Loose or intermittent connection 21
Tears, rips, holes in device, device material 21
Material integrity issue 21
Difficult to Program or Calibrate 20
Shelf life exceeded 18
Dislodged 18
Foreign material present in device 18
Dislodged or dislocated 16
Misplacement 16
Unexpected therapeutic results 15
Hybrid failure 15
Electrode(s), fracture of 14
Use of Device Issue 14
Fitting problem 14
Performance 14
Repair 13
Electrode contact(s), problem with 13
Incorrect display 13
Loss of or failure to bond 13
Material twisted 13
Improper device output 12
Stretched 12
Device damaged prior to use 12
Difficult to position 12
Magnetic interference 12
Peeled 11
Unintended movement 11
Device or device component damaged by another device 11
Programming issue 10
No code available 10
Total Device Problems 13804

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 1 0 0 0
Class II 1 2 0 0 0 1 2 2 1 2
Class III 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-24-2016
3 Medtronic Neuromodulation II Aug-19-2016
4 Medtronic Neuromodulation II May-15-2015
5 Medtronic Neuromodulation II Aug-18-2014
6 Medtronic Neuromodulation II Apr-29-2014
7 Medtronic Neuromodulation II Nov-14-2013
8 Medtronic Neuromodulation I May-01-2013
9 Medtronic Neuromodulation II Dec-19-2012
10 Medtronic Neuromodulation II Oct-27-2008
11 Medtronic Neuromodulation II Feb-05-2008
12 Medtronic Neuromodulation II Jun-15-2007

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