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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 2017
3 7 18 28 31 25 23 25 18 37 19

Device Problems
No Known Device Problem 2071
Device operates differently than expected 1855
High impedance 1511
Inappropriate shock 655
Unknown (for use when the device problem is not known) 578
Low impedance 561
Device displays error message 539
Device remains implanted 530
Break 465
Replace 461
Failure to deliver energy 448
Low battery 405
Premature discharge of battery 388
Migration of device or device component 366
No Information 358
Explanted 357
Electro-magnetic interference (EMI) 335
Battery issue 325
Charging issue 269
Communication or transmission issue 268
Other (for use when an appropriate device code cannot be identified) 263
Intermittent continuity 261
Implant, reprogramming of 231
Electromagnetic compatibility issue 217
Unintended collision 217
Malposition of device 198
Bent 190
Impedance issue 189
Fracture 187
Loss of power 122
Failure to interrogate 121
Connection issue 121
Therapy delivered to incorrect body area 118
Lead(s), breakage of 107
Device stops intermittently 101
Delayed charge time 97
Wire(s), breakage of 80
Improper or incorrect procedure or method 79
Material deformation 78
Shipping damage or problem 66
Unit inactivated 64
Implant, removal of 64
Device inoperable 63
Unstable 63
Electronic property issue 60
Positioning Issue 57
Pocket stimulation 53
Malfunction 50
Electro-magnetic interference (EMI), compatibility/incompatibility 48
Out-of-box failure 47
Device or device fragments location unknown 45
Kinked 45
Battery failure 44
No device output 44
Material integrity issue 44
Overheating of device or device component 43
Material erosion 37
Shock, electrical 37
Suspect EMI 36
Circuit breaker tripped 35
Disconnection 34
Device, or device fragments remain in patient 33
Device remains activated 32
Incorrect display 32
Circuit Failure 31
Device Issue 31
Implant, repositioning of 31
Foreign material present in device 30
Electrical shorting 28
Component(s), broken 25
Difficult to Program or Calibrate 25
Human-Device Interface Issue 24
No telemetry 23
Lead(s), fracture of 22
Shelf life exceeded 22
Tears, rips, holes in device, device material 21
Loose or intermittent connection 21
Unexpected therapeutic results 19
Use of Device Issue 18
Dislodged 18
Energy output to patient tissue incorrect 17
Material twisted 17
Dislodged or dislocated 16
Misplacement 16
Hybrid failure 15
Improper device output 15
Fitting problem 14
Electrode(s), fracture of 14
Performance 14
Stretched 13
Repair 13
Electrode contact(s), problem with 13
Loss of or failure to bond 13
Device or device component damaged by another device 13
Environmental control or utility issue 12
Device damaged prior to use 12
No code available 12
Peeled 12
Difficult to position 12
Magnetic interference 12
Total Device Problems 17562

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 1 0 0 0 0
Class II 1 2 0 0 0 1 2 2 1 3 0
Class III 0 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 Dec-03-2016
3 Medtronic Neuromodulation II Aug-24-2016
4 Medtronic Neuromodulation II Aug-19-2016
5 Medtronic Neuromodulation II May-15-2015
6 Medtronic Neuromodulation II Aug-18-2014
7 Medtronic Neuromodulation II Apr-29-2014
8 Medtronic Neuromodulation II Nov-14-2013
9 Medtronic Neuromodulation I May-01-2013
10 Medtronic Neuromodulation II Dec-19-2012
11 Medtronic Neuromodulation II Oct-27-2008
12 Medtronic Neuromodulation II Feb-05-2008
13 Medtronic Neuromodulation II Jun-15-2007

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