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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
ADVANCED NEUROMODULATION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
ADVANCED NEUROMODULATION SYSTEMS, INC. (ANS INC.)
  SUBSTANTIALLY EQUIVALENT 1
ANCHOR INNOVATION MEDICAL (A.I.M.)
  SUBSTANTIALLY EQUIVALENT 1
ANULEX TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
NALU MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 2
NALU MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
ST. JUDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
ST. JUDE MEDICAL NEUROMODULATION
  SUBSTANTIALLY EQUIVALENT 2
STIMWAVE TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
STIMWAVE TECHNOLOGIES INCORPORATED
  SUBSTANTIALLY EQUIVALENT 8

MDR Year MDR Reports MDR Events
2014 10848 10848
2015 7506 7506
2016 4555 4555
2017 5512 5512
2018 5244 5244
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 18764 18764
Device Operates Differently Than Expected 5223 5223
High impedance 3065 3065
Impedance Problem 1899 1899
Temperature Problem 1552 1552
Use of Device Problem 1449 1449
Communication or Transmission Problem 1415 1415
No Device Output 1116 1116
Migration or Expulsion of Device 978 978
Fracture 874 874
Low impedance 755 755
Charging Problem 698 698
Therapy Delivered to Incorrect Body Area 581 581
Disconnection 541 541
Nonstandard Device 508 508
Device Inoperable 494 494
Failure to Charge 361 361
Unintended Movement 299 299
Device Displays Incorrect Message 254 254
Break 241 241
Insufficient Information 222 222
Inappropriate/Inadequate Shock/Stimulation 207 207
Device Stops Intermittently 141 141
Difficult to Advance 124 124
Migration 110 110
Failure to Deliver Energy 109 109
Therapeutic or Diagnostic Output Failure 91 91
Failure to Advance 81 81
Kinked 79 79
Low Battery 75 75
Battery Problem 72 72
Malposition of Device 67 67
Improper or Incorrect Procedure or Method 61 61
Delayed Charge Time 59 59
Detachment Of Device Component 54 54
Cut In Material 49 49
Difficult to Insert 45 45
Detachment of Device or Device Component 44 44
Pocket Stimulation 42 42
Intermittent Continuity 41 41
Overheating of Device 39 39
Unintended Collision 37 37
Positioning Problem 37 37
Difficult to Remove 36 36
Material Fragmentation 31 31
Failure to Interrogate 30 30
Self-Activation or Keying 29 29
Connection Problem 29 29
Fluid/Blood Leak 24 24
Electromagnetic Interference 21 21
Appropriate Term/Code Not Available 21 21
Material Frayed 20 20
Patient-Device Incompatibility 20 20
Unstable 19 19
Unexpected Therapeutic Results 19 19
Premature Elective Replacement Indicator 19 19
Bent 18 18
Device Damaged by Another Device 18 18
Expulsion 18 18
Electromagnetic Compatibility Problem 16 16
Sticking 16 16
Premature Discharge of Battery 16 16
Material Integrity Problem 15 15
Energy Output To Patient Tissue Incorrect 14 14
Inadequacy of Device Shape and/or Size 14 14
Device Or Device Fragments Location Unknown 13 13
Premature End-of-Life Indicator 13 13
Device Dislodged or Dislocated 13 13
Corroded 11 11
Material Twisted/Bent 9 9
Device Handling Problem 9 9
Patient Device Interaction Problem 9 9
Material Deformation 8 8
Improper Device Output 8 8
Inadequate Instructions for Non-Healthcare Professional 8 8
Device Difficult to Program or Calibrate 8 8
Shipping Damage or Problem 8 8
Device Remains Activated 7 7
Material Separation 7 7
Contamination /Decontamination Problem 6 6
Material Erosion 6 6
Moisture or Humidity Problem 6 6
Operating System Becomes Nonfunctional 6 6
Human-Device Interface Problem 6 6
Torn Material 6 6
No Apparent Adverse Event 5 5
Material Split, Cut or Torn 5 5
Unintended Electrical Shock 5 5
Battery Problem: Low Impedance 5 5
Material Protrusion/Extrusion 5 5
Display or Visual Feedback Problem 5 5
Leak/Splash 5 5
Loss of Data 5 5
Failure to Deliver 4 4
Shelf Life Exceeded 4 4
Arcing of Electrodes 4 4
Component Missing 4 4
Energy Output Problem 4 4
Failure to Conduct 4 4
Coiled 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
Inadequate Pain Relief 19320 19320
Pain 3189 3189
Post Operative Wound Infection 2697 2697
Discomfort 2428 2428
No Known Impact Or Consequence To Patient 2078 2078
Burning Sensation 1802 1802
Fall 1583 1583
Therapeutic Effects, Unexpected 1475 1475
Unspecified Infection 1029 1029
Device Overstimulation of Tissue 990 990
Cerebrospinal Fluid Leakage 609 609
Erosion 442 442
Weight Changes 305 305
Scar Tissue 295 295
Headache 281 281
Fluid Discharge 246 246
Hematoma 237 237
Swelling 234 234
Headache, Lumbar Puncture 234 234
Weakness 222 222
Wound Dehiscence 218 218
No Consequences Or Impact To Patient 216 216
Numbness 211 211
Fever 199 199
Erythema 154 154
Neurological Deficit/Dysfunction 151 151
Death 137 137
Implant Pain 137 137
No Information 136 136
Impaired Healing 134 134
Skin Erosion 120 120
Complaint, Ill-Defined 113 113
Undesired Nerve Stimulation 107 107
Staphylococcus Aureus 99 99
Muscle Spasm(s) 97 97
No Clinical Signs, Symptoms or Conditions 91 91
Purulent Discharge 89 89
No Code Available 88 88
Electric Shock 85 85
Irritation 82 82
Abscess 76 76
Nausea 75 75
Therapeutic Response, Decreased 75 75
Bacterial Infection 71 71
Seizures 68 68
Inflammation 66 66
Paralysis 61 61
Seroma 60 60
Vomiting 58 58
Tingling 56 56
Muscle Weakness 55 55
Hemorrhage/Bleeding 55 55
Hypersensitivity/Allergic reaction 51 51
Paresis 51 51
Ambulation Difficulties 47 47
Abdominal Pain 43 43
Discharge 42 42
Cellulitis 36 36
Itching Sensation 36 36
Skin Irritation 33 33
Shock 32 32
Edema 32 32
Cardiopulmonary Arrest 30 30
Increased Sensitivity 30 30
Blood Loss 30 30
Shock from Patient Lead(s) 29 29
Sepsis 28 28
Respiratory Distress 28 28
Stenosis 27 27
Rash 26 26
Failure of Implant 26 26
Chest Pain 25 25
Skin Inflammation/ Irritation 25 25
Incontinence 24 24
Stroke/CVA 23 23
Chills 23 23
Low Oxygen Saturation 22 22
Bruise/Contusion 22 22
Insufficient Information 21 21
Myocardial Infarction 20 20
Cramp(s) 20 20
Reaction 18 18
Low Blood Pressure/ Hypotension 17 17
Swelling/ Edema 17 17
Loss of Range of Motion 15 15
Shaking/Tremors 15 15
Paraplegia 15 15
Neck Pain 14 14
Urinary Retention 14 14
Pocket Erosion 14 14
Hypoxia 14 14
Apnea 14 14
High Blood Pressure/ Hypertension 14 14
Bone Fracture(s) 14 14
Bradycardia 13 13
Twiddlers Syndrome 13 13
Dizziness 13 13
Neck Stiffness 13 13
Sweating 13 13
Device Embedded In Tissue or Plaque 13 13

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Neuromodulation Systems, Inc II Apr-21-2010
2 St. Jude Medical, Inc. II Sep-29-2014
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