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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, spinal-cord, totally implanted for pain relief
Product CodeLGW
Device Class 3

Premarket Approvals (PMA)
2015 2016 2017 2018 2019 2020
72 92 94 64 69 32

Device Problems
Adverse Event Without Identified Device or Use Problem 27892
Charging Problem 12982
Device Operates Differently Than Expected 9425
High impedance 7846
Battery Problem 7367
Failure to Deliver Energy 6682
Communication or Transmission Problem 5664
Insufficient Information 5236
Migration or Expulsion of Device 5089
Device Displays Incorrect Message 3585
Improper or Incorrect Procedure or Method 3563
Inappropriate Shock 3345
Unintended Collision 3320
Premature Elective Replacement Indicator 3282
Unexpected Therapeutic Results 3146
Use of Device Problem 3103
Therapeutic or Diagnostic Output Failure 3025
Migration 2955
Failure to Interrogate 2898
Energy Output Problem 2309
Low Battery 2178
No Device Output 2164
Delayed Charge Time 2094
Intermittent Continuity 2048
Therapy Delivered to Incorrect Body Area 1832
Malposition of device 1765
Break 1623
Overheating of Device 1622
Wireless Communication Problem 1600
Device Inoperable 1508
Impedance Problem 1352
Fracture 1296
Connection Problem 1254
Patient Device Interaction Problem 1146
Electromagnetic Compatibility Problem 1136
No Apparent Adverse Event 1129
Premature Discharge of Battery 1080
Failure to Charge 977
Unstable 954
Material Integrity Problem 900
Positioning Problem 845
Low impedance 787
Electromagnetic Interference 764
Application Program Freezes, Becomes Nonfunctional 653
Display or Visual Feedback Problem 464
Disconnection 416
Energy Output To Patient Tissue Incorrect 397
Defective Device 378
Device Or Device Fragments Location Unknown 322
Pocket Stimulation 260
Data Problem 254
Improper Device Output 225
Device Difficult to Program or Calibrate 197
Material Deformation 194
Patient-Device Incompatibility 179
Failure to Power Up 172
Premature End-of-Life Indicator 164
Telemetry Discrepancy 161
Loss of Data 159
Device Dislodged or Dislocated 140
Kinked 132
Temperature Problem 130
Difficult to Remove 129
Bent 128
Shipping Damage or Problem 122
Environmental Compatibility Problem 115
Difficult to Insert 114
Human-Device Interface Problem 108
Device Contamination with Chemical or Other Material 98
Unable to Obtain Readings 96
Inadequacy of Device Shape and/or Size 84
Detachment of Device or device Component 78
Material Frayed 77
Inadequate Instructions for Non-Healthcare Professional 68
Material Separation 62
Component Missing 58
Material Split, Cut or Torn 55
Device Stops Intermittently 55
Unexpected Shutdown 53
Intermittent Energy Output 46
Appropriate Term/Code Not Available 45
Material Protrusion / Extrusion 42
Electro-Static Discharge 39
Vibration 38
Material Fragmentation 38
Noise, Audible 34
Material Twisted / Bent 34
Unintended Movement 31
Power Problem 30
Degraded 30
Ambient Noise Problem 29
Failure to Fire 27
Device Issue 25
Device Damaged by Another Device 22
Shelf Life Exceeded 21
Failure to Align 20
Operating System Becomes Nonfunctional 19
Labelling, Instructions for Use or Training Problem 18
Mechanical Problem 17
Application Program Problem 14
Total Device Problems 161884

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Neuromodulation Corporation II May-26-2020
2 Medtronic Neuromodulation II Jul-13-2018
3 Medtronic Neuromodulation II Jun-07-2016
4 Medtronic Neuromodulation II Feb-23-2016
5 Medtronic Neuromodulation II Jun-26-2015
6 Nuvectra II Dec-17-2016
7 Nuvectra II May-03-2016
8 QiG Group LLC II Mar-18-2016
9 St. Jude Medical, Inc. II Oct-17-2017
10 St. Jude Medical, Inc. II Jul-07-2017

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