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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 4

Device Problems
No Known Device Problem 1079
High impedance 1021
Device operates differently than expected 820
Unknown (for use when the device problem is not known) 578
Device remains implanted 530
Replace 461
Inappropriate shock 450
Explanted 357
No Information 357
Low impedance 293
Electro-magnetic interference (EMI) 279
Other (for use when an appropriate device code cannot be identified) 263
Migration of device or device component 240
Implant, reprogramming of 231
Premature discharge of battery 217
Break 215
Fracture 185
Bent 166
Intermittent continuity 153
Low battery 153
Device displays error message 151
Loss of power 122
Failure to deliver energy 109
Impedance issue 108
Lead(s), breakage of 107
Battery issue 107
Device stops intermittently 101
Malposition of device 90
Communication or transmission issue 88
Wire(s), breakage of 80
Electromagnetic compatibility issue 72
Unit inactivated 64
Implant, removal of 64
Connection issue 62
Device inoperable 60
Electronic property issue 60
Charging issue 56
Unintended collision 51
Malfunction 50
Electro-magnetic interference (EMI), compatibility/incompatibility 48
Out-of-box failure 47
Kinked 44
Improper or incorrect procedure or method 44
Battery failure 44
Failure to interrogate 40
Positioning Issue 37
Material erosion 37
Shock, electrical 37
Suspect EMI 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
Component(s), broken 25
Delayed charge time 24
Therapy delivered to incorrect body area 24
No telemetry 23
Material deformation 22
Lead(s), fracture of 22
Loose or intermittent connection 21
Tears, rips, holes in device, device material 21
Disconnection 20
Pocket stimulation 19
Dislodged 18
Overheating of device or device component 17
Shipping damage or problem 17
Difficult to Program or Calibrate 17
Dislodged or dislocated 16
Device or device fragments location unknown 16
Misplacement 16
Hybrid failure 15
Human-Device Interface Issue 15
Performance 14
Unexpected therapeutic results 14
Material integrity issue 14
Electrode(s), fracture of 14
Fitting problem 14
Foreign material present in device 13
Repair 13
Electrode contact(s), problem with 13
Loss of or failure to bond 13
Unstable 12
Magnetic interference 12
Stretched 12
Difficult to position 12
Device damaged prior to use 12
Unintended movement 11
Material twisted 11
Programming issue 10
Misconnection 10
Failure, intermittent 10
Program, failure to 10
Device or device component damaged by another device 10
Shelf life exceeded 10
Insulation degradation 10
Low battery impedance 10
No device output 9
Total Device Problems 10946

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

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