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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 94 59

MDR Year MDR Reports MDR Events
2020 28106 28112
2021 24333 24354
2022 23271 23287
2023 33527 33536
2024 35073 35083
2025 28743 28747

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 36739 36751
Charging Problem 22488 22491
High impedance 20017 20022
Battery Problem 19207 19214
Migration 17149 17157
Insufficient Information 15729 15732
Unexpected Therapeutic Results 11309 11310
Wireless Communication Problem 10512 10513
Therapeutic or Diagnostic Output Failure 10274 10285
Overheating of Device 10011 10017
Communication or Transmission Problem 6734 6736
Failure to Deliver Energy 5535 5537
Improper or Incorrect Procedure or Method 5282 5283
Inappropriate/Inadequate Shock/Stimulation 5055 5058
Migration or Expulsion of Device 5039 5039
Energy Output Problem 4415 4415
Connection Problem 4314 4314
Failure to Interrogate 4147 4147
Fracture 3880 3880
Delayed Charge Time 3747 3748
Failure to Power Up 2729 2729
Impedance Problem 2617 2619
Display or Visual Feedback Problem 2498 2498
Unintended Collision 2340 2341
Material Integrity Problem 2252 2252
Patient Device Interaction Problem 1894 1894
Break 1801 1810
Defective Device 1741 1747
Intermittent Continuity 1733 1734
Premature Discharge of Battery 1415 1415
Therapy Delivered to Incorrect Body Area 1397 1397
Malposition of Device 1371 1371
Operating System Becomes Nonfunctional 1129 1129
Use of Device Problem 1015 1015
Positioning Problem 1005 1006
Low impedance 959 959
Data Problem 957 957
Electromagnetic Compatibility Problem 920 920
Unstable 769 769
Application Program Problem 729 729
No Apparent Adverse Event 685 685
Premature Elective Replacement Indicator 580 580
Electromagnetic Interference 578 579
Disconnection 526 526
Patient-Device Incompatibility 521 526
Material Frayed 487 487
No Device Output 476 476
Computer Software Problem 331 331
Temperature Problem 314 314
Pocket Stimulation 244 244

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Pain Relief 56953 56964
No Clinical Signs, Symptoms or Conditions 50298 50310
Pain 20014 20026
Failure of Implant 12183 12198
Insufficient Information 8393 8400
Implant Pain 7951 7952
Unspecified Infection 5898 5900
Discomfort 5123 5123
No Code Available 5079 5080
Undesired Nerve Stimulation 4343 4350
Burning Sensation 4212 4218
Electric Shock 3444 3445
No Known Impact Or Consequence To Patient 3338 3339
Post Operative Wound Infection 2194 2194
No Consequences Or Impact To Patient 2009 2011
Bacterial Infection 1623 1625
Therapeutic Effects, Unexpected 1538 1538
Wound Dehiscence 1181 1184
Fluid Discharge 1114 1116
Device Overstimulation of Tissue 1065 1066
Swelling/ Edema 1018 1018
Ambulation Difficulties 988 989
Numbness 988 990
Cerebrospinal Fluid Leakage 865 866
Erosion 860 862
Hematoma 844 845
Impaired Healing 768 768
Headache 759 760
Muscle Weakness 717 718
Burn(s) 572 572
Erythema 564 564
Scar Tissue 508 509
Paralysis 497 499
Paresthesia 486 486
Therapeutic Response, Decreased 482 482
Complaint, Ill-Defined 466 466
Cramp(s) /Muscle Spasm(s) 460 460
Fever 442 443
Fall 423 425
Pocket Erosion 414 414
Hypersensitivity/Allergic reaction 391 391
Purulent Discharge 383 383
Skin Inflammation/ Irritation 383 383
Sleep Dysfunction 367 367
Device Embedded In Tissue or Plaque 302 302
Nausea 282 282
Seroma 263 263
Hemorrhage/Bleeding 258 258
Inflammation 250 250
Foreign Body In Patient 240 240

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 Boston Scientific Neuromodulation Corporation II May-26-2020
6 Medtronic Neuromodulation II Apr-08-2025
7 Medtronic Neuromodulation II Nov-13-2024
8 Medtronic Neuromodulation II Oct-17-2024
9 Medtronic Neuromodulation II Apr-26-2024
10 Medtronic Neuromodulation II Jan-22-2024
11 Medtronic Neuromodulation II Nov-20-2023
12 Medtronic Neuromodulation II Sep-29-2023
13 Medtronic Neuromodulation II Jul-21-2023
14 Medtronic Neuromodulation II Jun-29-2023
15 Medtronic Neuromodulation II Jan-06-2023
16 Medtronic Neuromodulation II Aug-25-2022
17 Medtronic Neuromodulation II Aug-24-2022
18 Medtronic Neuromodulation II May-23-2022
19 Medtronic Neuromodulation II Nov-24-2021
20 Medtronic Neuromodulation II Jul-28-2021
21 Medtronic Neuromodulation II May-06-2021
22 Medtronic Neuromodulation II Jan-14-2021
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