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TPLC
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Device
stimulator, spinal-cord, totally implanted for pain relief
Product Code
LGW
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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