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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 5244 5244
2019 643 643
2020 466 466
2021 332 332
2022 209 209
2023 157 157

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5249 5249
High impedance 752 752
Fracture 237 237
Impedance Problem 173 173
Low impedance 129 129
Disconnection 107 107
Break 92 92
Migration 92 92
Therapeutic or Diagnostic Output Failure 83 83
Insufficient Information 57 57
Use of Device Problem 36 36
Migration or Expulsion of Device 21 21
Material Fragmentation 20 20
Inappropriate/Inadequate Shock/Stimulation 19 19
Device Operates Differently Than Expected 15 15
Positioning Problem 15 15
Patient-Device Incompatibility 14 14
Difficult to Insert 13 13
Improper or Incorrect Procedure or Method 12 12
No Device Output 11 11
Appropriate Term/Code Not Available 10 10
Premature Elective Replacement Indicator 9 9
Device Damaged by Another Device 9 9
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
Material Twisted/Bent 5 5
Unintended Electrical Shock 5 5
Battery Problem 5 5
Shipping Damage or Problem 5 5
Detachment of Device or Device Component 5 5
Expulsion 4 4
Connection Problem 4 4
Malposition of Device 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
Component Missing 3 3
Material Protrusion/Extrusion 3 3
Output Problem 2 2
Communication or Transmission Problem 2 2
Difficult to Open or Close 2 2
Human-Device Interface Problem 2 2
Electrical Shorting 2 2
Low Battery 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
Unintended Movement 1 1
Physical Resistance/Sticking 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
Inadequacy of Device Shape and/or Size 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
Defective Device 1 1
Device Or Device Fragments Location Unknown 1 1
Failure to Advance 1 1
Expiration Date Error 1 1
Charging Problem 1 1
Invalid Sensing 1 1
Material Perforation 1 1
Vibration 1 1
Electromagnetic Compatibility Problem 1 1
Improper Device Output 1 1
Improper Flow or Infusion 1 1
Installation-Related Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Pain Relief 3415 3415
Post Operative Wound Infection 775 775
Unspecified Infection 567 567
No Known Impact Or Consequence To Patient 391 391
Pain 347 347
Fall 277 277
Discomfort 256 256
No Consequences Or Impact To Patient 207 207
Cerebrospinal Fluid Leakage 144 144
Erosion 121 121
Implant Pain 109 109
Therapeutic Effects, Unexpected 94 94
No Clinical Signs, Symptoms or Conditions 82 82
Device Overstimulation of Tissue 80 80
Wound Dehiscence 75 75
Hematoma 59 59
Weakness 58 58
Numbness 55 55
Headache, Lumbar Puncture 53 53
Fluid Discharge 51 51
Fever 50 50
Headache 41 41
Scar Tissue 41 41
Skin Erosion 39 39
Impaired Healing 36 36
Purulent Discharge 34 34
Electric Shock 29 29
Swelling 28 28
Burning Sensation 27 27
Death 24 24
Hemorrhage/Bleeding 24 24
Skin Inflammation/ Irritation 24 24
Weight Changes 23 23
Abdominal Pain 22 22
Hypersensitivity/Allergic reaction 21 21
Seizures 21 21
Bacterial Infection 19 19
Abscess 18 18
Erythema 18 18
Undesired Nerve Stimulation 18 18
Insufficient Information 18 18
Nausea 16 16
Skin Irritation 16 16
Discharge 16 16
Failure of Implant 15 15
Inflammation 14 14
Neurological Deficit/Dysfunction 14 14
Seroma 14 14
No Information 14 14
Swelling/ Edema 13 13
Staphylococcus Aureus 13 13
Paralysis 13 13
Irritation 13 13
Muscle Spasm(s) 12 12
Muscle Weakness 10 10
Rash 9 9
Chest Pain 9 9
Itching Sensation 8 8
Chills 8 8
No Code Available 8 8
Shock from Patient Lead(s) 7 7
Tingling 7 7
Sepsis 7 7
Cellulitis 7 7
Paresis 6 6
Stenosis 6 6
Neck Stiffness 6 6
Low Oxygen Saturation 6 6
Blood Loss 6 6
Ambulation Difficulties 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Skin Infection 6 6
Device Embedded In Tissue or Plaque 5 5
Patient Problem/Medical Problem 5 5
Sweating 5 5
Neck Pain 5 5
Respiratory Distress 5 5
Nerve Damage 5 5
Muscle Stimulation 5 5
Pulmonary Embolism 5 5
Bruise/Contusion 4 4
Stroke/CVA 4 4
Granuloma 4 4
Myocardial Infarction 4 4
Neuropathy 4 4
Hypoxia 4 4
Thrombus 4 4
Vomiting 4 4
Needle Stick/Puncture 4 4
Abdominal Cramps 4 4
Foreign Body In Patient 4 4
Vaso-Vagal Response 4 4
Paraplegia 3 3
Shaking/Tremors 3 3
Spinal Cord Injury 3 3
Urticaria 3 3
Loss of Range of Motion 3 3
Low Blood Pressure/ Hypotension 3 3
Head Injury 3 3
Foreign Body Reaction 3 3

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