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)
2020 2021 2022 2023 2024 2025
52 56 60 63 94 31

MDR Year MDR Reports MDR Events
2020 28106 28106
2021 24333 24333
2022 23272 23272
2023 33528 33528
2024 35074 35074
2025 12958 12958

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 32733 32733
Charging Problem 20520 20520
Battery Problem 17878 17878
High impedance 17837 17837
Migration 15528 15528
Insufficient Information 14293 14293
Unexpected Therapeutic Results 10138 10138
Wireless Communication Problem 9645 9645
Therapeutic or Diagnostic Output Failure 9565 9565
Overheating of Device 9414 9414
Communication or Transmission Problem 6175 6175
Improper or Incorrect Procedure or Method 5011 5011
Failure to Deliver Energy 4855 4855
Migration or Expulsion of Device 4638 4638
Inappropriate/Inadequate Shock/Stimulation 4479 4479
Connection Problem 4186 4186
Energy Output Problem 3845 3845
Failure to Interrogate 3809 3809
Fracture 3584 3584
Delayed Charge Time 3446 3446
Failure to Power Up 2721 2721
Impedance Problem 2374 2374
Display or Visual Feedback Problem 2370 2370
Material Integrity Problem 2214 2214
Unintended Collision 2129 2129
Patient Device Interaction Problem 1692 1692
Break 1633 1633
Defective Device 1582 1582
Intermittent Continuity 1520 1520
Premature Discharge of Battery 1254 1254
Therapy Delivered to Incorrect Body Area 1231 1231
Malposition of Device 1212 1212
Operating System Becomes Nonfunctional 1092 1092
Positioning Problem 913 913
Use of Device Problem 906 906
Low impedance 872 872
Data Problem 851 851
Electromagnetic Compatibility Problem 822 822
Application Program Problem 711 711
Unstable 709 709
No Apparent Adverse Event 593 593
Premature Elective Replacement Indicator 579 579
Electromagnetic Interference 511 511
Disconnection 487 487
Patient-Device Incompatibility 478 478
Material Frayed 474 474
No Device Output 398 398
Computer Software Problem 321 321
Temperature Problem 291 291
Pocket Stimulation 226 226

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Pain Relief 52720 52720
No Clinical Signs, Symptoms or Conditions 45034 45034
Pain 17477 17477
Failure of Implant 11025 11025
Insufficient Information 7130 7130
Implant Pain 6928 6928
Unspecified Infection 5276 5276
No Code Available 5079 5079
Discomfort 4695 4695
Undesired Nerve Stimulation 3900 3900
Burning Sensation 3887 3887
No Known Impact Or Consequence To Patient 3338 3338
Electric Shock 3074 3074
No Consequences Or Impact To Patient 2009 2010
Post Operative Wound Infection 1988 1988
Therapeutic Effects, Unexpected 1538 1538
Bacterial Infection 1431 1431
Wound Dehiscence 1061 1061
Fluid Discharge 994 994
Device Overstimulation of Tissue 914 914
Swelling/ Edema 903 903
Numbness 884 884
Ambulation Difficulties 866 866
Cerebrospinal Fluid Leakage 783 783
Erosion 782 782
Hematoma 776 776
Impaired Healing 690 690
Headache 676 676
Muscle Weakness 629 629
Burn(s) 538 538
Therapeutic Response, Decreased 482 482
Erythema 471 471
Complaint, Ill-Defined 466 466
Scar Tissue 466 466
Paralysis 458 458
Paresthesia 408 408
Cramp(s) /Muscle Spasm(s) 402 402
Fever 394 394
Pocket Erosion 384 384
Fall 373 373
Skin Inflammation/ Irritation 360 360
Hypersensitivity/Allergic reaction 348 348
Purulent Discharge 341 341
Sleep Dysfunction 321 321
Device Embedded In Tissue or Plaque 268 268
Seroma 245 245
Nausea 245 245
Hemorrhage/Bleeding 236 236
Inflammation 221 221
Abdominal Pain 192 192

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical II Jul-16-2024
2 Abbott Medical I Sep-11-2023
3 Boston Scientific Neuromodulation Corporation II Aug-14-2024
4 Boston Scientific Neuromodulation Corporation II May-26-2020
5 Medtronic Neuromodulation II Apr-08-2025
6 Medtronic Neuromodulation II Nov-13-2024
7 Medtronic Neuromodulation II Oct-17-2024
8 Medtronic Neuromodulation II Apr-26-2024
9 Medtronic Neuromodulation II Jan-22-2024
10 Medtronic Neuromodulation II Nov-20-2023
11 Medtronic Neuromodulation II Sep-29-2023
12 Medtronic Neuromodulation II Jul-21-2023
13 Medtronic Neuromodulation II Jun-29-2023
14 Medtronic Neuromodulation II Jan-06-2023
15 Medtronic Neuromodulation II Aug-25-2022
16 Medtronic Neuromodulation II Aug-24-2022
17 Medtronic Neuromodulation II May-23-2022
18 Medtronic Neuromodulation II Nov-24-2021
19 Medtronic Neuromodulation II Jul-28-2021
20 Medtronic Neuromodulation II May-06-2021
21 Medtronic Neuromodulation II Jan-14-2021
-
-