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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, spinal-cord, implanted (pain relief)
Product CodeGZB
Regulation Number 882.5880
Device Class 2


Premarket Reviews
ManufacturerDecision
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 76 76

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1264 1264
Migration 102 102
Fracture 99 99
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 16 16
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 450 450
Post Operative Wound Infection 357 357
Unspecified Infection 352 352
Pain 144 144
Implant Pain 135 135
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
Electric Shock 30 30
Skin Erosion 30 30
Failure of Implant 25 25
Skin Inflammation/ Irritation 25 25
Fever 24 24
Insufficient Information 21 21
Purulent Discharge 19 19
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
Impaired Healing 12 12
Numbness 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
Scar Tissue 7 7
Rash 7 7
Cerebrospinal Fluid Leakage 7 7
Death 6 6
Paralysis 6 6
Skin Infection 6 6
Shock from Patient Lead(s) 6 6
No Code Available 6 6
Device Embedded In Tissue or Plaque 5 5
Ambulation Difficulties 5 5
Therapeutic Effects, Unexpected 5 5
Inflammation 5 5
Irritation 4 4
Hemorrhage/Bleeding 4 4
Seizures 4 4
Chills 4 4
Needle Stick/Puncture 4 4
Foreign Body In Patient 4 4
Cramp(s) /Muscle Spasm(s) 3 3
Low Oxygen Saturation 3 3
Drug Resistant Bacterial Infection 3 3
Nerve Damage 3 3
Hematoma 3 3
Memory Loss/Impairment 3 3
Muscle Weakness 2 2
Nausea 2 2
Itching Sensation 2 2
Granuloma 2 2
Weakness 2 2
Infection, Indirect 2 2
Therapeutic Response, Decreased 2 2
Injury 2 2
Discharge 2 2
Perforation 2 2
Unspecified Tissue Injury 2 2
Shaking/Tremors 2 2
Neck Pain 2 2
Cognitive Changes 2 2
Weight Changes 2 2
Irritability 2 2
Blister 2 2
Paresthesia 2 2
Patient Problem/Medical Problem 2 2
Radiation Exposure, Unintended 1 1
Missing Value Reason 1 1
Convulsion/Seizure 1 1
Syncope/Fainting 1 1
Neuralgia 1 1
Eye Pain 1 1
No Information 1 1
Nodule 1 1
Tooth Fracture 1 1
Spinal Cord Injury 1 1
Loss of consciousness 1 1
Choking 1 1
Palpitations 1 1
Sweating 1 1
Sleep Dysfunction 1 1
Easy Bruising 1 1
Local Reaction 1 1
Staphylococcus Aureus 1 1
Tinnitus 1 1
Tissue Damage 1 1
Urinary Tract Infection 1 1

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