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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 27

Device Problems
No Known Device Problem 1344
High impedance 1184
Device operates differently than expected 1156
Unknown (for use when the device problem is not known) 578
Device remains implanted 530
Inappropriate shock 501
Replace 461
Low impedance 366
Explanted 357
No Information 357
Electro-magnetic interference (EMI) 294
Migration of device or device component 288
Break 284
Device displays error message 274
Other (for use when an appropriate device code cannot be identified) 263
Premature discharge of battery 257
Implant, reprogramming of 231
Low battery 229
Failure to deliver energy 196
Fracture 185
Intermittent continuity 183
Bent 169
Battery issue 165
Communication or transmission issue 140
Impedance issue 129
Loss of power 122
Electromagnetic compatibility issue 119
Malposition of device 118
Lead(s), breakage of 107
Unintended collision 101
Device stops intermittently 101
Charging issue 97
Wire(s), breakage of 80
Failure to interrogate 74
Connection issue 72
Implant, removal of 64
Unit inactivated 64
Device inoperable 60
Electronic property issue 60
Improper or incorrect procedure or method 52
Malfunction 50
Electro-magnetic interference (EMI), compatibility/incompatibility 48
Out-of-box failure 47
Kinked 44
Battery failure 44
Therapy delivered to incorrect body area 43
Positioning Issue 43
Material deformation 40
Shock, electrical 37
Material erosion 37
Suspect EMI 36
Circuit breaker tripped 35
Delayed charge time 34
Device, or device fragments remain in patient 33
Shipping damage or problem 32
Device remains activated 32
Pocket stimulation 32
Circuit Failure 31
Implant, repositioning of 31
Device Issue 31
Electrical shorting 28
Disconnection 28
Device or device fragments location unknown 26
Component(s), broken 25
Overheating of device or device component 24
Unstable 24
No telemetry 23
Human-Device Interface Issue 22
Lead(s), fracture of 22
Loose or intermittent connection 21
Tears, rips, holes in device, device material 21
No device output 21
Material integrity issue 19
Dislodged 18
Difficult to Program or Calibrate 17
Misplacement 16
Dislodged or dislocated 16
Foreign material present in device 15
Hybrid failure 15
Electrode(s), fracture of 14
Performance 14
Fitting problem 14
Unexpected therapeutic results 14
Repair 13
Electrode contact(s), problem with 13
Incorrect display 13
Loss of or failure to bond 13
Stretched 12
Device damaged prior to use 12
Shelf life exceeded 12
Use of Device Issue 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
Total Device Problems 12826

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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