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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 12

Device Problems
No Known Device Problem 1146
High impedance 1065
Device operates differently than expected 897
Unknown (for use when the device problem is not known) 578
Device remains implanted 530
Inappropriate shock 461
Replace 461
Explanted 357
No Information 357
Low impedance 308
Electro-magnetic interference (EMI) 280
Other (for use when an appropriate device code cannot be identified) 263
Migration of device or device component 245
Implant, reprogramming of 231
Break 229
Premature discharge of battery 227
Device displays error message 195
Fracture 185
Low battery 179
Bent 167
Intermittent continuity 156
Failure to deliver energy 132
Battery issue 126
Loss of power 122
Impedance issue 112
Lead(s), breakage of 107
Device stops intermittently 101
Communication or transmission issue 101
Malposition of device 93
Electromagnetic compatibility issue 85
Wire(s), breakage of 80
Connection issue 67
Charging issue 65
Implant, removal of 64
Unit inactivated 64
Unintended collision 61
Device inoperable 60
Electronic property issue 60
Malfunction 50
Failure to interrogate 50
Electro-magnetic interference (EMI), compatibility/incompatibility 48
Out-of-box failure 47
Improper or incorrect procedure or method 47
Kinked 44
Battery failure 44
Positioning Issue 39
Shock, electrical 37
Material erosion 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
Material deformation 30
Electrical shorting 28
Therapy delivered to incorrect body area 27
Pocket stimulation 26
Shipping damage or problem 26
Component(s), broken 25
Delayed charge time 25
No telemetry 23
Lead(s), fracture of 22
Loose or intermittent connection 21
Tears, rips, holes in device, device material 21
Disconnection 20
Dislodged 18
Overheating of device or device component 18
Difficult to Program or Calibrate 17
Device or device fragments location unknown 17
Material integrity issue 17
Dislodged or dislocated 16
Human-Device Interface Issue 16
Misplacement 16
Hybrid failure 15
Electrode(s), fracture of 14
No device output 14
Performance 14
Unstable 14
Fitting problem 14
Unexpected therapeutic results 14
Foreign material present in device 14
Repair 13
Electrode contact(s), problem with 13
Loss of or failure to bond 13
Stretched 12
Device damaged prior to use 12
Shelf life exceeded 12
Difficult to position 12
Magnetic interference 12
Material twisted 11
Unintended movement 11
Programming issue 10
Low battery impedance 10
Device or device component damaged by another device 10
Misconnection 10
Program, failure to 10
Failure, intermittent 10
Insulation degradation 10
Total Device Problems 11422

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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