• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 5

Device Problems
No Known Device Problem 1752
Device operates differently than expected 1574
High impedance 1359
Unknown (for use when the device problem is not known) 578
Inappropriate shock 573
Device remains implanted 530
Low impedance 467
Replace 461
Device displays error message 422
Break 375
No Information 358
Explanted 357
Premature discharge of battery 337
Migration of device or device component 331
Low battery 326
Failure to deliver energy 325
Electro-magnetic interference (EMI) 308
Other (for use when an appropriate device code cannot be identified) 263
Battery issue 247
Implant, reprogramming of 231
Intermittent continuity 216
Communication or transmission issue 191
Fracture 185
Bent 179
Charging issue 179
Malposition of device 167
Electromagnetic compatibility issue 166
Impedance issue 162
Unintended collision 161
Loss of power 122
Lead(s), breakage of 107
Connection issue 103
Device stops intermittently 101
Failure to interrogate 95
Wire(s), breakage of 80
Therapy delivered to incorrect body area 74
Delayed charge time 65
Implant, removal of 64
Unit inactivated 64
Improper or incorrect procedure or method 63
Device inoperable 60
Electronic property issue 60
Material deformation 59
Positioning Issue 50
Malfunction 50
Shipping damage or problem 50
Pocket stimulation 48
Electro-magnetic interference (EMI), compatibility/incompatibility 48
Out-of-box failure 47
Kinked 44
Battery failure 44
Unstable 43
Overheating of device or device component 40
Device or device fragments location unknown 40
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
No device output 32
Circuit Failure 31
Disconnection 31
Device Issue 31
Implant, repositioning of 31
Material integrity issue 30
Electrical shorting 28
Component(s), broken 25
Foreign material present in device 24
Human-Device Interface Issue 24
No telemetry 23
Lead(s), fracture of 22
Difficult to Program or Calibrate 22
Tears, rips, holes in device, device material 21
Loose or intermittent connection 21
Shelf life exceeded 20
Incorrect display 19
Dislodged 18
Unexpected therapeutic results 17
Use of Device Issue 16
Misplacement 16
Dislodged or dislocated 16
Hybrid failure 15
Electrode(s), fracture of 14
Performance 14
Fitting problem 14
Material twisted 14
Improper device output 13
Repair 13
Electrode contact(s), problem with 13
Loss of or failure to bond 13
Stretched 12
Device damaged prior to use 12
Peeled 12
Difficult to position 12
Magnetic interference 12
Device or device component damaged by another device 12
No code available 11
Unintended movement 11
Programming issue 10
Total Device Problems 15356

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

-
-