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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
2
MDR Year
MDR Reports
MDR Events
2018
5247
5247
2019
643
643
2020
466
466
2021
332
332
2022
212
212
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
5156
5156
High impedance
754
754
Fracture
235
235
Impedance Problem
173
173
Low impedance
129
129
Disconnection
107
107
Break
87
87
Migration
82
82
Therapeutic or Diagnostic Output Failure
81
81
Insufficient Information
39
39
Use of Device Problem
35
35
Migration or Expulsion of Device
21
21
Inappropriate/Inadequate Shock/Stimulation
19
19
Material Fragmentation
18
18
Device Operates Differently Than Expected
15
15
Positioning Problem
14
14
Patient-Device Incompatibility
12
12
No Device Output
11
11
Difficult to Insert
10
10
Premature Elective Replacement Indicator
9
9
Improper or Incorrect Procedure or Method
9
9
Device Damaged by Another Device
9
9
Appropriate Term/Code Not Available
8
8
Difficult to Remove
7
7
Device Dislodged or Dislocated
6
6
Device Displays Incorrect Message
6
6
Patient Device Interaction Problem
6
6
Temperature Problem
5
5
Material Split, Cut or Torn
5
5
Unintended Electrical Shock
5
5
Shipping Damage or Problem
5
5
Material Twisted/Bent
5
5
Expulsion
4
4
Connection Problem
4
4
Detachment of Device or Device Component
4
4
Cut In Material
4
4
Overheating of Device
4
4
Kinked
4
4
Detachment Of Device Component
4
4
No Apparent Adverse Event
4
4
Material Frayed
3
3
Failure to Charge
3
3
Therapy Delivered to Incorrect Body Area
3
3
Device Stops Intermittently
3
3
Battery Problem
3
3
Component Missing
3
3
Malposition of Device
2
2
Low Battery
2
2
Difficult to Open or Close
2
2
Communication or Transmission Problem
2
2
Electrical Shorting
2
2
Material Protrusion/Extrusion
2
2
Loss of Power
2
2
Material Separation
2
2
Material Erosion
2
2
Mechanical Problem
2
2
Unintended Collision
2
2
Loosening of Implant Not Related to Bone-Ingrowth
2
2
Wireless Communication Problem
1
1
Energy Output Problem
1
1
Nonstandard Device
1
1
Melted
1
1
Electromagnetic Interference
1
1
Shelf Life Exceeded
1
1
Unexpected Therapeutic Results
1
1
Device Inoperable
1
1
Peeled/Delaminated
1
1
Difficult To Position
1
1
Off-Label Use
1
1
Material Puncture/Hole
1
1
Product Quality Problem
1
1
Output Problem
1
1
Improper Device Output
1
1
Installation-Related Problem
1
1
Device Contaminated During Manufacture or Shipping
1
1
Material Integrity Problem
1
1
Electromagnetic Compatibility Problem
1
1
Device Or Device Fragments Location Unknown
1
1
Expiration Date Error
1
1
Charging Problem
1
1
Invalid Sensing
1
1
Material Perforation
1
1
Vibration
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Inadequate Pain Relief
3386
3386
Post Operative Wound Infection
743
743
Unspecified Infection
553
553
No Known Impact Or Consequence To Patient
391
391
Pain
338
338
Fall
277
277
Discomfort
253
253
No Consequences Or Impact To Patient
207
207
Cerebrospinal Fluid Leakage
142
142
Erosion
121
121
Therapeutic Effects, Unexpected
94
94
Implant Pain
88
88
Device Overstimulation of Tissue
80
80
Wound Dehiscence
73
73
No Clinical Signs, Symptoms or Conditions
73
73
Hematoma
59
59
Weakness
58
58
Numbness
55
55
Headache, Lumbar Puncture
53
53
Fluid Discharge
49
49
Fever
46
46
Scar Tissue
41
41
Headache
39
39
Skin Erosion
37
37
Impaired Healing
35
35
Purulent Discharge
32
32
Electric Shock
29
29
Swelling
28
28
Burning Sensation
25
25
Death
24
24
Hemorrhage/Bleeding
24
24
Weight Changes
23
23
Skin Inflammation/ Irritation
23
23
Abdominal Pain
21
21
Seizures
21
21
Abscess
18
18
Erythema
18
18
Hypersensitivity/Allergic reaction
18
18
Undesired Nerve Stimulation
17
17
Nausea
16
16
Bacterial Infection
16
16
Skin Irritation
16
16
Discharge
16
16
Seroma
14
14
Neurological Deficit/Dysfunction
14
14
Failure of Implant
14
14
No Information
14
14
Irritation
13
13
Staphylococcus Aureus
13
13
Inflammation
12
12
Muscle Spasm(s)
12
12
Paralysis
12
12
Muscle Weakness
10
10
Rash
9
9
Chest Pain
9
9
Swelling/ Edema
9
9
No Code Available
8
8
Itching Sensation
8
8
Cellulitis
7
7
Tingling
7
7
Shock from Patient Lead(s)
7
7
Blood Loss
6
6
Ambulation Difficulties
6
6
Chills
6
6
Sepsis
6
6
Stenosis
6
6
Neck Stiffness
6
6
Low Oxygen Saturation
6
6
Paresis
6
6
Nerve Damage
5
5
Muscle Stimulation
5
5
Pulmonary Embolism
5
5
Sweating
5
5
Neck Pain
5
5
Respiratory Distress
5
5
Patient Problem/Medical Problem
5
5
Device Embedded In Tissue or Plaque
5
5
Insufficient Information
4
4
Skin Infection
4
4
Foreign Body In Patient
4
4
Abdominal Cramps
4
4
Vaso-Vagal Response
4
4
Thrombus
4
4
Vomiting
4
4
Bruise/Contusion
4
4
Stroke/CVA
4
4
Granuloma
4
4
Neuropathy
4
4
Hypoxia
4
4
Low Blood Pressure/ Hypotension
3
3
Myocardial Infarction
3
3
Head Injury
3
3
Foreign Body Reaction
3
3
Dyspnea
3
3
Bradycardia
3
3
Aspiration/Inhalation
3
3
Atrial Fibrillation
3
3
Adhesion(s)
3
3
Loss of Range of Motion
3
3
Spinal Cord Injury
3
3
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