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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)
2019 2020 2021 2022 2023 2024
69 52 56 60 63 58

MDR Year MDR Reports MDR Events
2019 30039 30039
2020 28106 28106
2021 24333 24333
2022 23272 23272
2023 33527 33527
2024 24663 24664

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 37573 37573
Charging Problem 20656 20656
High impedance 17336 17336
Battery Problem 17092 17092
Migration 14795 14796
Insufficient Information 14614 14614
Unexpected Therapeutic Results 10358 10358
Therapeutic or Diagnostic Output Failure 9872 9872
Wireless Communication Problem 9284 9284
Overheating of Device 8756 8756
Communication or Transmission Problem 6149 6149
Improper or Incorrect Procedure or Method 5690 5690
Failure to Deliver Energy 5100 5100
Migration or Expulsion of Device 4813 4813
Inappropriate/Inadequate Shock/Stimulation 4487 4487
Connection Problem 4104 4104
Energy Output Problem 4062 4062
Failure to Interrogate 3818 3818
Fracture 3537 3537
Delayed Charge Time 3503 3503
Failure to Power Up 2740 2740
Unintended Collision 2589 2589
Impedance Problem 2467 2467
Display or Visual Feedback Problem 2289 2289
Material Integrity Problem 2209 2209
Patient Device Interaction Problem 1956 1956
Break 1725 1725
Intermittent Continuity 1666 1666
Premature Discharge of Battery 1655 1655
Premature Elective Replacement Indicator 1584 1584
Defective Device 1572 1572
Use of Device Problem 1520 1520
Therapy Delivered to Incorrect Body Area 1277 1277
Malposition of Device 1257 1257
No Device Output 1143 1143
Low impedance 1063 1063
Operating System Becomes Nonfunctional 1040 1040
Positioning Problem 908 908
Electromagnetic Compatibility Problem 900 900
Data Problem 813 813
Unstable 765 765
Application Program Problem 697 697
Electromagnetic Interference 586 586
Disconnection 556 556
No Apparent Adverse Event 546 546
Patient-Device Incompatibility 511 511
Material Frayed 452 452
Application Program Freezes, Becomes Nonfunctional 383 383
Computer Software Problem 312 312
Temperature Problem 310 310

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Pain Relief 55443 55444
No Clinical Signs, Symptoms or Conditions 37730 37730
Pain 17503 17503
No Code Available 10738 10738
Failure of Implant 7303 7303
No Known Impact Or Consequence To Patient 7180 7180
Insufficient Information 5775 5775
Discomfort 5679 5679
Unspecified Infection 5544 5544
Implant Pain 5475 5475
No Consequences Or Impact To Patient 4222 4223
Therapeutic Effects, Unexpected 3890 3890
Undesired Nerve Stimulation 3878 3878
Burning Sensation 3837 3837
Electric Shock 3150 3150
Post Operative Wound Infection 1998 1998
Bacterial Infection 1445 1445
Therapeutic Response, Decreased 1234 1234
Complaint, Ill-Defined 1134 1134
Device Overstimulation of Tissue 1070 1070
Wound Dehiscence 1055 1055
Fluid Discharge 1028 1028
Cerebrospinal Fluid Leakage 956 956
Numbness 923 923
Erosion 895 895
Ambulation Difficulties 880 880
Hematoma 827 827
Swelling/ Edema 733 733
Headache 722 722
Impaired Healing 674 674
Fall 605 605
Muscle Weakness 599 599
Burn(s) 552 552
Scar Tissue 520 520
Paralysis 498 498
Fever 458 458
Erythema 440 440
Pocket Erosion 409 409
Purulent Discharge 395 395
Swelling 370 370
Hypersensitivity/Allergic reaction 360 360
Death 326 326
Paresthesia 326 326
Cramp(s) /Muscle Spasm(s) 324 324
Sleep Dysfunction 323 323
Skin Inflammation/ Irritation 297 297
Seroma 279 279
Device Embedded In Tissue or Plaque 275 275
Nausea 274 274
Inflammation 241 241

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