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TPLC
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Device
stimulator, spinal-cord, implanted (pain relief)
Product Code
GZB
Regulation Number
882.5880
Device Class
2
Premarket Reviews
Manufacturer
Decision
NALU MEDICAL, INC
SUBSTANTIALLY EQUIVALENT
2
NALU MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
4
STIMWAVE TECHNOLOGIES INC.
SUBSTANTIALLY EQUIVALENT
1
STIMWAVE TECHNOLOGIES INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
643
643
2020
466
466
2021
332
332
2022
209
209
2023
237
237
2024
54
54
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1248
1248
Migration
100
100
Fracture
98
98
High impedance
93
93
Therapeutic or Diagnostic Output Failure
83
83
Break
58
58
Insufficient Information
52
52
Impedance Problem
43
43
Disconnection
27
27
Use of Device Problem
22
22
Inappropriate/Inadequate Shock/Stimulation
17
17
Material Fragmentation
15
15
Migration or Expulsion of Device
14
14
Improper or Incorrect Procedure or Method
14
14
Appropriate Term/Code Not Available
11
11
Patient-Device Incompatibility
10
10
No Device Output
9
9
Difficult to Insert
9
9
Positioning Problem
8
8
Patient Device Interaction Problem
7
7
Low impedance
7
7
Difficult to Remove
5
5
Unintended Electrical Shock
5
5
No Apparent Adverse Event
4
4
Malposition of Device
4
4
Battery Problem
4
4
Expulsion
4
4
Shipping Damage or Problem
4
4
Overheating of Device
4
4
Component Missing
3
3
Failure to Advance
2
2
Mechanical Problem
2
2
Material Erosion
2
2
Failure to Charge
2
2
Loss of Power
2
2
Human-Device Interface Problem
2
2
Connection Problem
2
2
Detachment of Device or Device Component
2
2
Device Dislodged or Dislocated
2
2
Electrical Shorting
2
2
Output Problem
2
2
Material Protrusion/Extrusion
2
2
Material Split, Cut or Torn
2
2
Physical Resistance/Sticking
1
1
Unintended Movement
1
1
Material Twisted/Bent
1
1
Improper Flow or Infusion
1
1
Installation-Related Problem
1
1
Device Contaminated During Manufacture or Shipping
1
1
Electromagnetic Compatibility Problem
1
1
Charging Problem
1
1
Material Puncture/Hole
1
1
Product Quality Problem
1
1
Therapy Delivered to Incorrect Body Area
1
1
Nonstandard Device
1
1
Energy Output Problem
1
1
Melted
1
1
Expiration Date Error
1
1
Defective Device
1
1
Application Program Problem
1
1
Material Perforation
1
1
Peeled/Delaminated
1
1
Inadequacy of Device Shape and/or Size
1
1
Vibration
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Inadequate Pain Relief
448
448
Post Operative Wound Infection
353
353
Unspecified Infection
348
348
Pain
143
143
Implant Pain
128
128
No Clinical Signs, Symptoms or Conditions
91
91
No Consequences Or Impact To Patient
69
69
Discomfort
62
62
Erosion
49
49
No Known Impact Or Consequence To Patient
39
39
Wound Dehiscence
38
38
Fluid Discharge
34
34
Skin Erosion
30
30
Electric Shock
30
30
Skin Inflammation/ Irritation
25
25
Fever
24
24
Failure of Implant
24
24
Insufficient Information
19
19
Purulent Discharge
17
17
Swelling/ Edema
17
17
Undesired Nerve Stimulation
16
16
Burning Sensation
16
16
Bacterial Infection
14
14
Hypersensitivity/Allergic reaction
13
13
Skin Irritation
13
13
Numbness
12
12
Impaired Healing
12
12
Sepsis
11
11
Fall
11
11
Abscess
10
10
Headache
10
10
Swelling
10
10
Device Overstimulation of Tissue
9
9
Erythema
9
9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
9
9
Seroma
8
8
Rash
7
7
Cerebrospinal Fluid Leakage
7
7
Scar Tissue
7
7
Death
6
6
No Code Available
6
6
Skin Infection
6
6
Shock from Patient Lead(s)
6
6
Paralysis
6
6
Ambulation Difficulties
5
5
Inflammation
5
5
Therapeutic Effects, Unexpected
5
5
Seizures
4
4
Chills
4
4
Foreign Body In Patient
4
4
Device Embedded In Tissue or Plaque
4
4
Needle Stick/Puncture
4
4
Hemorrhage/Bleeding
4
4
Irritation
4
4
Hematoma
3
3
Low Oxygen Saturation
3
3
Nerve Damage
3
3
Memory Loss/Impairment
3
3
Drug Resistant Bacterial Infection
3
3
Cramp(s) /Muscle Spasm(s)
3
3
Paresthesia
2
2
Muscle Weakness
2
2
Infection, Indirect
2
2
Weakness
2
2
Unspecified Tissue Injury
2
2
Nausea
2
2
Irritability
2
2
Discharge
2
2
Cognitive Changes
2
2
Perforation
2
2
Neck Pain
2
2
Injury
2
2
Granuloma
2
2
Shaking/Tremors
2
2
Blister
2
2
Itching Sensation
2
2
Therapeutic Response, Decreased
2
2
Weight Changes
2
2
Patient Problem/Medical Problem
2
2
Edema
1
1
Syncope/Fainting
1
1
Local Reaction
1
1
Urinary Tract Infection
1
1
Blurred Vision
1
1
Tinnitus
1
1
Myocardial Infarction
1
1
Missing Value Reason
1
1
No Information
1
1
Loss of consciousness
1
1
Easy Bruising
1
1
Neuralgia
1
1
Distress
1
1
Nodule
1
1
Sweating
1
1
Staphylococcus Aureus
1
1
Aneurysm
1
1
Visual Disturbances
1
1
Convulsion/Seizure
1
1
Sedation
1
1
Spinal Cord Injury
1
1
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