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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 17

Device Problems
No Known Device Problem 1214
High impedance 1113
Device operates differently than expected 987
Unknown (for use when the device problem is not known) 578
Device remains implanted 530
Inappropriate shock 473
Replace 461
Explanted 357
No Information 357
Low impedance 329
Electro-magnetic interference (EMI) 285
Other (for use when an appropriate device code cannot be identified) 263
Migration of device or device component 257
Break 245
Premature discharge of battery 233
Implant, reprogramming of 231
Device displays error message 224
Low battery 197
Fracture 185
Bent 168
Intermittent continuity 161
Failure to deliver energy 142
Battery issue 141
Loss of power 122
Communication or transmission issue 115
Impedance issue 115
Lead(s), breakage of 107
Device stops intermittently 101
Malposition of device 100
Electromagnetic compatibility issue 91
Charging issue 81
Wire(s), breakage of 80
Unintended collision 75
Connection issue 69
Implant, removal of 64
Unit inactivated 64
Device inoperable 60
Electronic property issue 60
Failure to interrogate 56
Malfunction 50
Electro-magnetic interference (EMI), compatibility/incompatibility 48
Improper or incorrect procedure or method 48
Out-of-box failure 47
Kinked 44
Battery failure 44
Positioning Issue 43
Shock, electrical 37
Material erosion 37
Suspect EMI 36
Circuit breaker tripped 35
Device, or device fragments remain in patient 33
Material deformation 33
Device remains activated 32
Therapy delivered to incorrect body area 31
Circuit Failure 31
Implant, repositioning of 31
Device Issue 31
Electrical shorting 28
Delayed charge time 27
Shipping damage or problem 27
Pocket stimulation 26
Component(s), broken 25
No telemetry 23
Disconnection 22
Lead(s), fracture of 22
Overheating of device or device component 22
Tears, rips, holes in device, device material 21
Loose or intermittent connection 21
Dislodged 18
Device or device fragments location unknown 18
Human-Device Interface Issue 17
Material integrity issue 17
Unstable 17
Difficult to Program or Calibrate 17
Misplacement 16
Dislodged or dislocated 16
Hybrid failure 15
Electrode(s), fracture of 14
No device output 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
Device or device component damaged by another device 11
Material twisted 11
Unintended movement 11
Programming issue 10
Low battery impedance 10
Misconnection 10
Program, failure to 10
Failure, intermittent 10
Insulation degradation 10
Total Device Problems 11873

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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