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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)
2020 2021 2022 2023 2024 2025
52 56 60 63 93 5

MDR Year MDR Reports MDR Events
2020 28106 28106
2021 24333 24333
2022 23272 23272
2023 33528 33528
2024 35075 35078
2025 2520 2520

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 30286 30287
Charging Problem 19211 19211
Battery Problem 16594 16594
High impedance 16410 16410
Migration 14479 14480
Insufficient Information 13449 13450
Unexpected Therapeutic Results 9356 9356
Wireless Communication Problem 9074 9074
Therapeutic or Diagnostic Output Failure 9039 9039
Overheating of Device 8959 8959
Communication or Transmission Problem 5771 5771
Improper or Incorrect Procedure or Method 4807 4807
Failure to Deliver Energy 4471 4471
Migration or Expulsion of Device 4370 4370
Inappropriate/Inadequate Shock/Stimulation 4123 4123
Connection Problem 4077 4077
Failure to Interrogate 3564 3564
Energy Output Problem 3473 3473
Fracture 3353 3353
Delayed Charge Time 3231 3231
Failure to Power Up 2714 2714
Display or Visual Feedback Problem 2277 2277
Impedance Problem 2199 2199
Material Integrity Problem 2170 2170
Unintended Collision 2015 2015
Patient Device Interaction Problem 1574 1574
Break 1530 1530
Defective Device 1465 1465
Intermittent Continuity 1415 1415
Premature Discharge of Battery 1213 1213
Therapy Delivered to Incorrect Body Area 1106 1106
Malposition of Device 1091 1091
Operating System Becomes Nonfunctional 1067 1067
Use of Device Problem 838 838
Positioning Problem 833 833
Low impedance 825 825
Data Problem 784 784
Electromagnetic Compatibility Problem 760 760
Application Program Problem 705 705
Unstable 661 661
Premature Elective Replacement Indicator 578 578
No Apparent Adverse Event 543 543
Electromagnetic Interference 472 472
Disconnection 460 460
Material Frayed 458 458
Patient-Device Incompatibility 449 449
No Device Output 363 363
Computer Software Problem 314 314
Temperature Problem 273 273
Pocket Stimulation 212 212

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Pain Relief 49721 49722
No Clinical Signs, Symptoms or Conditions 41705 41705
Pain 15816 15818
Failure of Implant 9366 9366
Insufficient Information 6460 6460
Implant Pain 6290 6290
No Code Available 5079 5079
Unspecified Infection 4912 4912
Discomfort 4419 4419
Burning Sensation 3640 3640
Undesired Nerve Stimulation 3586 3586
No Known Impact Or Consequence To Patient 3338 3338
Electric Shock 2836 2836
No Consequences Or Impact To Patient 2009 2010
Post Operative Wound Infection 1851 1851
Therapeutic Effects, Unexpected 1538 1538
Bacterial Infection 1318 1318
Wound Dehiscence 981 981
Fluid Discharge 925 925
Swelling/ Edema 847 848
Device Overstimulation of Tissue 834 834
Numbness 830 830
Ambulation Difficulties 780 780
Erosion 739 739
Cerebrospinal Fluid Leakage 729 729
Hematoma 726 726
Impaired Healing 630 630
Headache 623 623
Muscle Weakness 601 602
Burn(s) 518 518
Therapeutic Response, Decreased 482 482
Complaint, Ill-Defined 466 466
Scar Tissue 435 435
Erythema 426 426
Paralysis 425 425
Fever 373 373
Pocket Erosion 365 365
Paresthesia 365 365
Cramp(s) /Muscle Spasm(s) 363 363
Fall 353 353
Skin Inflammation/ Irritation 333 333
Purulent Discharge 324 324
Hypersensitivity/Allergic reaction 324 324
Sleep Dysfunction 292 292
Device Embedded In Tissue or Plaque 242 242
Seroma 239 239
Nausea 227 227
Hemorrhage/Bleeding 220 220
Inflammation 202 202
Abdominal Pain 183 183

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 Nov-13-2024
6 Medtronic Neuromodulation II Oct-17-2024
7 Medtronic Neuromodulation II Apr-26-2024
8 Medtronic Neuromodulation II Jan-22-2024
9 Medtronic Neuromodulation II Nov-20-2023
10 Medtronic Neuromodulation II Sep-29-2023
11 Medtronic Neuromodulation II Jul-21-2023
12 Medtronic Neuromodulation II Jun-29-2023
13 Medtronic Neuromodulation II Jan-06-2023
14 Medtronic Neuromodulation II Aug-25-2022
15 Medtronic Neuromodulation II Aug-24-2022
16 Medtronic Neuromodulation II May-23-2022
17 Medtronic Neuromodulation II Nov-24-2021
18 Medtronic Neuromodulation II Jul-28-2021
19 Medtronic Neuromodulation II May-06-2021
20 Medtronic Neuromodulation II Jan-14-2021
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