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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
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
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