Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 show TPLC since Back to Search Results
Device stimulator, spinal-cord, totally implanted for pain relief
Product CodeLGW
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
56 60 63 94 65 22

MDR Year MDR Reports MDR Events
2021 24333 24354
2022 23269 23285
2023 33526 33535
2024 35074 35084
2025 31442 31446
2026 9846 9846

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 34095 34105
Charging Problem 21627 21630
High impedance 18894 18899
Battery Problem 18214 18221
Migration 15652 15659
Insufficient Information 13064 13067
Unexpected Therapeutic Results 10777 10777
Overheating of Device 10043 10049
Wireless Communication Problem 9551 9552
Therapeutic or Diagnostic Output Failure 7403 7413
Communication or Transmission Problem 6568 6570
Failure to Deliver Energy 5197 5199
Inappropriate/Inadequate Shock/Stimulation 4781 4784
Migration or Expulsion of Device 4622 4622
Connection Problem 4280 4280
Energy Output Problem 4079 4079
Failure to Interrogate 4010 4010
Improper or Incorrect Procedure or Method 3883 3884
Delayed Charge Time 3549 3550
Fracture 3537 3537
Failure to Power Up 2711 2711
Display or Visual Feedback Problem 2513 2513
Impedance Problem 2411 2413
Material Integrity Problem 2240 2240
Unintended Collision 1992 1993
Patient Device Interaction Problem 1655 1655
Break 1636 1641
Intermittent Continuity 1541 1542
Defective Device 1531 1537
Malposition of Device 1324 1324
Therapy Delivered to Incorrect Body Area 1281 1281
Operating System Becomes Nonfunctional 1218 1218
Premature Discharge of Battery 1205 1205
Use of Device Problem 951 951
Positioning Problem 916 917
Data Problem 912 912
Low impedance 832 832
Application Program Problem 820 820
Electromagnetic Compatibility Problem 806 806
No Apparent Adverse Event 731 731
Unstable 700 700
Electromagnetic Interference 505 506
Material Frayed 480 480
No Device Output 422 422
Disconnection 396 396
Computer Software Problem 328 328
Patient-Device Incompatibility 322 326
Temperature Problem 272 272
Device Dislodged or Dislocated 210 210
Pocket Stimulation 208 208

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 53712 53723
Inadequate Pain Relief 50016 50026
Pain 19277 19286
Failure of Implant 11855 11867
Insufficient Information 9070 9077
Implant Pain 8737 8738
Unspecified Infection 5368 5370
Discomfort 4369 4369
Burning Sensation 3972 3976
Undesired Nerve Stimulation 3879 3886
Electric Shock 3247 3248
Post Operative Wound Infection 1946 1946
Bacterial Infection 1541 1543
Wound Dehiscence 1123 1126
Swelling/ Edema 1103 1103
Fluid Discharge 1035 1037
Device Overstimulation of Tissue 962 963
Ambulation Difficulties 949 950
Numbness 921 923
Erosion 762 764
Hematoma 741 742
Cerebrospinal Fluid Leakage 738 739
Impaired Healing 729 729
Muscle Weakness 726 727
Headache 722 723
Erythema 567 567
Paresthesia 554 554
Burn(s) 494 494
Cramp(s) /Muscle Spasm(s) 480 480
Paralysis 448 450
Fall 444 446
Scar Tissue 442 443
Fever 404 405
Skin Inflammation/ Irritation 402 402
Pocket Erosion 370 370
Hypersensitivity/Allergic reaction 367 367
Purulent Discharge 362 362
Sleep Dysfunction 353 353
Nausea 264 264
Hemorrhage/Bleeding 259 259
Foreign Body In Patient 257 257
Device Embedded In Tissue or Plaque 252 252
No Code Available 249 249
Inflammation 234 234
Seroma 216 216
Itching Sensation 212 212
Sepsis 194 194
Abdominal Pain 183 183
Bruise/Contusion 178 178
Weight Changes 165 165

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical II Nov-07-2025
2 Abbott Medical II Jul-16-2024
3 Abbott Medical I Sep-11-2023
4 Boston Scientific Neuromodulation Corporation II Aug-14-2024
5 Medtronic Neuromodulation II Jan-09-2026
6 Medtronic Neuromodulation II Dec-23-2025
7 Medtronic Neuromodulation II Apr-08-2025
8 Medtronic Neuromodulation II Nov-13-2024
9 Medtronic Neuromodulation II Oct-17-2024
10 Medtronic Neuromodulation II Apr-26-2024
11 Medtronic Neuromodulation II Jan-22-2024
12 Medtronic Neuromodulation II Nov-20-2023
13 Medtronic Neuromodulation II Sep-29-2023
14 Medtronic Neuromodulation II Jul-21-2023
15 Medtronic Neuromodulation II Jun-29-2023
16 Medtronic Neuromodulation II Jan-06-2023
17 Medtronic Neuromodulation II Aug-25-2022
18 Medtronic Neuromodulation II Aug-24-2022
19 Medtronic Neuromodulation II May-23-2022
20 Medtronic Neuromodulation II Nov-24-2021
21 Medtronic Neuromodulation II Jul-28-2021
22 Medtronic Neuromodulation II May-06-2021
23 Medtronic Neuromodulation II Jan-14-2021
-
-