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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 22

Device Problems
No Known Device Problem 1277
High impedance 1139
Device operates differently than expected 1063
Unknown (for use when the device problem is not known) 578
Device remains implanted 530
Inappropriate shock 486
Replace 461
Explanted 357
No Information 357
Low impedance 346
Electro-magnetic interference (EMI) 287
Migration of device or device component 266
Other (for use when an appropriate device code cannot be identified) 263
Break 260
Device displays error message 245
Premature discharge of battery 243
Implant, reprogramming of 231
Low battery 212
Fracture 185
Intermittent continuity 171
Failure to deliver energy 170
Bent 168
Battery issue 152
Communication or transmission issue 126
Loss of power 122
Impedance issue 119
Malposition of device 109
Lead(s), breakage of 107
Electromagnetic compatibility issue 103
Device stops intermittently 101
Charging issue 87
Unintended collision 83
Wire(s), breakage of 80
Connection issue 69
Failure to interrogate 65
Unit inactivated 64
Implant, removal of 64
Electronic property issue 60
Device inoperable 60
Malfunction 50
Improper or incorrect procedure or method 49
Electro-magnetic interference (EMI), compatibility/incompatibility 48
Out-of-box failure 47
Kinked 44
Battery failure 44
Positioning Issue 43
Shock, electrical 37
Material erosion 37
Suspect EMI 36
Material deformation 35
Circuit breaker tripped 35
Therapy delivered to incorrect body area 35
Device, or device fragments remain in patient 33
Device remains activated 32
Circuit Failure 31
Implant, repositioning of 31
Device Issue 31
Delayed charge time 30
Electrical shorting 28
Shipping damage or problem 28
Pocket stimulation 27
Component(s), broken 25
Disconnection 25
Overheating of device or device component 24
No telemetry 23
Lead(s), fracture of 22
Loose or intermittent connection 21
Unstable 21
Tears, rips, holes in device, device material 21
Device or device fragments location unknown 21
Human-Device Interface Issue 19
Dislodged 18
Difficult to Program or Calibrate 17
Material integrity issue 17
Dislodged or dislocated 16
No device output 16
Misplacement 16
Hybrid failure 15
Electrode(s), fracture of 14
Performance 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
Incorrect display 11
Device or device component damaged by another device 11
Material twisted 11
Unintended movement 11
Programming issue 10
Low battery impedance 10
Failure, intermittent 10
Insulation degradation 10
Misconnection 10
Total Device Problems 12277

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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