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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
111
111
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1287
1287
Migration
104
104
Fracture
99
99
High impedance
93
93
Therapeutic or Diagnostic Output Failure
83
83
Break
58
58
Insufficient Information
53
53
Impedance Problem
46
46
Disconnection
27
27
Use of Device Problem
22
22
Inappropriate/Inadequate Shock/Stimulation
17
17
Material Fragmentation
17
17
Migration or Expulsion of Device
15
15
Improper or Incorrect Procedure or Method
14
14
Appropriate Term/Code Not Available
14
14
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 Unsafe to Use in Environment
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
Off-Label Use
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
456
456
Post Operative Wound Infection
363
363
Unspecified Infection
358
358
Pain
145
145
Implant Pain
140
140
No Clinical Signs, Symptoms or Conditions
94
94
No Consequences Or Impact To Patient
69
69
Discomfort
64
64
Erosion
54
54
Wound Dehiscence
40
40
No Known Impact Or Consequence To Patient
39
39
Fluid Discharge
36
36
Electric Shock
31
31
Skin Erosion
31
31
Skin Inflammation/ Irritation
27
27
Failure of Implant
25
25
Fever
24
24
Purulent Discharge
21
21
Insufficient Information
21
21
Swelling/ Edema
17
17
Undesired Nerve Stimulation
16
16
Burning Sensation
16
16
Hypersensitivity/Allergic reaction
14
14
Bacterial Infection
14
14
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
Scar Tissue
7
7
Cerebrospinal Fluid Leakage
7
7
Death
6
6
Paralysis
6
6
Skin Infection
6
6
Shock from Patient Lead(s)
6
6
Device Embedded In Tissue or Plaque
6
6
No Code Available
6
6
Ambulation Difficulties
5
5
Inflammation
5
5
Therapeutic Effects, Unexpected
5
5
Seizures
4
4
Chills
4
4
Irritation
4
4
Hemorrhage/Bleeding
4
4
Foreign Body In Patient
4
4
Needle Stick/Puncture
4
4
Low Oxygen Saturation
3
3
Drug Resistant Bacterial Infection
3
3
Cramp(s) /Muscle Spasm(s)
3
3
Hematoma
3
3
Itching Sensation
3
3
Memory Loss/Impairment
3
3
Nerve Damage
3
3
Weakness
2
2
Injury
2
2
Discharge
2
2
Infection, Indirect
2
2
Therapeutic Response, Decreased
2
2
Perforation
2
2
Nausea
2
2
Muscle Weakness
2
2
Granuloma
2
2
Blister
2
2
Paresthesia
2
2
Shaking/Tremors
2
2
Cognitive Changes
2
2
Patient Problem/Medical Problem
2
2
Weight Changes
2
2
Irritability
2
2
Neck Pain
2
2
Unspecified Tissue Injury
2
2
Sweating
1
1
Tooth Fracture
1
1
Spinal Cord Injury
1
1
Choking
1
1
Palpitations
1
1
Sleep Dysfunction
1
1
Eye Pain
1
1
Easy Bruising
1
1
Nodule
1
1
Missing Value Reason
1
1
Convulsion/Seizure
1
1
Syncope/Fainting
1
1
Neuralgia
1
1
No Information
1
1
Radiation Exposure, Unintended
1
1
Edema
1
1
Cyst(s)
1
1
Bradycardia
1
1
Cellulitis
1
1
Aneurysm
1
1
Arrhythmia
1
1
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