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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 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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