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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 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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