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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, electrical, implantable, for incontinence
Definition PMAs to be filed by 12/26/96 (61 FR 50707 (9/27/96))
Product CodeEZW
Regulation Number 876.5270
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
24 43 34 46 32 7

MDR Year MDR Reports MDR Events
2019 4772 4772
2020 4118 4118
2021 4479 4479
2022 4318 4318
2023 5056 5056
2024 1338 1338

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 5817 5817
Adverse Event Without Identified Device or Use Problem 5452 5452
Migration or Expulsion of Device 3474 3474
Failure to Deliver Energy 2941 2941
Inappropriate/Inadequate Shock/Stimulation 2427 2427
Energy Output Problem 2269 2269
Battery Problem 2229 2229
Communication or Transmission Problem 1981 1981
Unintended Collision 1854 1854
Break 1794 1794
Failure to Interrogate 1314 1314
Electromagnetic Compatibility Problem 1240 1240
Therapy Delivered to Incorrect Body Area 1131 1131
High impedance 1129 1129
Electromagnetic Interference 957 957
Patient Device Interaction Problem 785 785
Malposition of Device 735 735
Charging Problem 526 526
Intermittent Continuity 478 478
Unstable 435 435
Overheating of Device 403 403
Impedance Problem 378 378
Data Problem 368 368
Positioning Problem 322 322
Pocket Stimulation 298 298
Connection Problem 295 295
Difficult to Remove 243 243
Premature Discharge of Battery 216 216
Application Program Problem 215 215
Material Deformation 188 188
Disconnection 174 174
Low impedance 144 144
Delayed Charge Time 144 144
Display or Visual Feedback Problem 123 123
Environmental Compatibility Problem 95 95
Human-Device Interface Problem 93 93
Appropriate Term/Code Not Available 86 86
No Device Output 73 73
Migration 69 69
Vibration 66 66
Shipping Damage or Problem 66 66
Loss of Data 59 59
Unexpected Therapeutic Results 58 58
Therapeutic or Diagnostic Output Failure 58 58
Peeled/Delaminated 57 57
Difficult to Insert 54 54
Material Twisted/Bent 47 47
Stretched 33 33
Improper or Incorrect Procedure or Method 32 32
Device Contamination with Chemical or Other Material 31 31
Use of Device Problem 28 28
Failure to Charge 26 26
Noise, Audible 23 23
Inadequate Instructions for Non-Healthcare Professional 22 22
Ambient Noise Problem 22 22
Device Difficult to Program or Calibrate 19 19
Labelling, Instructions for Use or Training Problem 17 17
Unable to Obtain Readings 15 15
Material Perforation 15 15
Degraded 14 14
Component Missing 12 12
Wireless Communication Problem 11 11
Lack of Effect 11 11
Inadequacy of Device Shape and/or Size 10 10
Electro-Static Discharge 10 10
Entrapment of Device 10 10
Fracture 10 10
Device Markings/Labelling Problem 8 8
Unauthorized Access to Computer System 8 8
Application Program Freezes, Becomes Nonfunctional 6 6
Activation, Positioning or Separation Problem 6 6
Failure to Power Up 6 6
Patient-Device Incompatibility 5 5
Material Protrusion/Extrusion 5 5
Device Contaminated During Manufacture or Shipping 4 4
Device Dislodged or Dislocated 4 4
Defective Device 4 4
Detachment of Device or Device Component 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Circuit Failure 3 3
No Apparent Adverse Event 3 3
Material Split, Cut or Torn 2 2
Failure to Conduct 2 2
Material Fragmentation 2 2
Material Frayed 2 2
Unsealed Device Packaging 2 2
Failure to Read Input Signal 2 2
Material Too Rigid or Stiff 1 1
Intermittent Shock/Stimulation 1 1
Defective Component 1 1
Inadequate or Insufficient Training 1 1
Device-Device Incompatibility 1 1
Difficult to Advance 1 1
Structural Problem 1 1
Loose or Intermittent Connection 1 1
Nonstandard Device 1 1
Material Erosion 1 1
No Display/Image 1 1
Contamination 1 1
Use of Incorrect Control/Treatment Settings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5676 5676
Pain 4753 4753
Insufficient Information 4425 4425
Incontinence 2829 2829
Electric Shock 2431 2431
Discomfort 2248 2248
No Known Impact Or Consequence To Patient 2224 2224
Therapeutic Effects, Unexpected 2221 2221
Urinary Retention 1852 1852
Therapeutic Response, Decreased 1513 1513
Urinary Frequency 1486 1486
Undesired Nerve Stimulation 1354 1354
Unspecified Infection 1312 1312
Complaint, Ill-Defined 1284 1284
Burning Sensation 720 720
Device Embedded In Tissue or Plaque 659 659
Micturition Urgency 612 612
Device Overstimulation of Tissue 558 558
Sleep Dysfunction 422 422
Hemorrhage/Bleeding 365 365
Ambulation Difficulties 353 353
Constipation 353 353
Urinary Tract Infection 350 350
Diarrhea 296 296
Urinary Incontinence 286 286
Failure of Implant 216 216
Cramp(s) /Muscle Spasm(s) 198 198
Swelling/ Edema 196 196
Malaise 196 196
Numbness 192 192
Dysuria 187 187
Fluid Discharge 177 177
Pocket Erosion 170 170
Erythema 165 165
Paresthesia 147 147
Itching Sensation 134 134
Wound Dehiscence 119 119
Weight Changes 113 113
Scar Tissue 109 109
Abdominal Pain 106 106
Nausea 105 105
Swelling 100 100
Bruise/Contusion 98 98
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 98 98
Post Operative Wound Infection 81 81
Inflammation 80 80
Fever 79 79
Bacterial Infection 77 77
Nerve Damage 77 77
Hypersensitivity/Allergic reaction 76 76
Tingling 75 75
Impaired Healing 75 75
Fecal Incontinence 75 75
Muscle Spasm(s) 73 73
Erosion 68 68
Fall 67 67
Skin Inflammation/ Irritation 64 64
Headache 59 59
Purulent Discharge 58 58
Foreign Body Reaction 57 57
Fatigue 55 55
Dizziness 52 52
Distress 52 52
Flatus 51 51
Hematoma 49 49
Twitching 49 49
Anxiety 49 49
Vomiting 46 46
Rash 46 46
Muscle Weakness 45 45
Cramp(s) 45 45
Shaking/Tremors 43 43
Implant Pain 43 43
Abdominal Distention 42 42
Muscular Rigidity 42 42
Loss of consciousness 34 34
Hematuria 31 31
Cognitive Changes 29 29
High Blood Pressure/ Hypertension 29 29
Abscess 29 29
Sepsis 27 27
Foreign Body In Patient 27 27
Confusion/ Disorientation 25 25
Irritation 25 25
Seroma 24 24
Dehydration 23 23
Depression 23 23
Paralysis 20 20
Skin Irritation 20 20
Abdominal Cramps 19 19
No Code Available 19 19
Unspecified Tissue Injury 19 19
Tissue Breakdown 18 18
Intraoperative Pain 17 17
Cellulitis 16 16
Tachycardia 15 15
Chills 15 15
Neuropathy 15 15
Chest Pain 14 14
Irritability 14 14

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Neuromodulation II Aug-10-2023
2 Medtronic Neuromodulation II Apr-22-2022
3 Medtronic Neuromodulation II Nov-24-2021
4 Medtronic Neuromodulation II Jun-07-2019
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