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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 14

MDR Year MDR Reports MDR Events
2019 4772 4772
2020 4118 4118
2021 4479 4479
2022 4318 4318
2023 5056 5056
2024 2685 2685

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 6125 6125
Adverse Event Without Identified Device or Use Problem 5785 5785
Migration or Expulsion of Device 3713 3713
Failure to Deliver Energy 3089 3089
Inappropriate/Inadequate Shock/Stimulation 2532 2532
Energy Output Problem 2399 2399
Battery Problem 2311 2311
Communication or Transmission Problem 2089 2089
Unintended Collision 1951 1951
Break 1894 1894
Failure to Interrogate 1388 1388
Electromagnetic Compatibility Problem 1313 1313
High impedance 1197 1197
Therapy Delivered to Incorrect Body Area 1174 1174
Electromagnetic Interference 1021 1021
Patient Device Interaction Problem 814 814
Malposition of Device 788 788
Charging Problem 553 553
Intermittent Continuity 495 495
Unstable 457 457
Overheating of Device 431 431
Impedance Problem 394 394
Data Problem 392 392
Positioning Problem 334 334
Pocket Stimulation 314 314
Connection Problem 311 311
Difficult to Remove 263 263
Premature Discharge of Battery 245 245
Application Program Problem 215 215
Material Deformation 202 202
Disconnection 187 187
Delayed Charge Time 151 151
Low impedance 148 148
Display or Visual Feedback Problem 131 131
Environmental Compatibility Problem 97 97
Human-Device Interface Problem 94 94
Therapeutic or Diagnostic Output Failure 94 94
Appropriate Term/Code Not Available 87 87
Migration 80 80
No Device Output 78 78
Vibration 74 74
Shipping Damage or Problem 67 67
Loss of Data 60 60
Unexpected Therapeutic Results 58 58
Peeled/Delaminated 57 57
Difficult to Insert 56 56
Material Twisted/Bent 48 48
Stretched 34 34
Device Contamination with Chemical or Other Material 33 33
Improper or Incorrect Procedure or Method 32 32
Failure to Charge 31 31
Use of Device Problem 29 29
Noise, Audible 24 24
Inadequate Instructions for Non-Healthcare Professional 22 22
Ambient Noise Problem 22 22
Device Difficult to Program or Calibrate 19 19
Material Perforation 18 18
Labelling, Instructions for Use or Training Problem 18 18
Lack of Effect 18 18
Unable to Obtain Readings 16 16
Degraded 14 14
Electro-Static Discharge 13 13
Component Missing 12 12
Fracture 11 11
Wireless Communication Problem 11 11
Unauthorized Access to Computer System 10 10
Entrapment of Device 10 10
Inadequacy of Device Shape and/or Size 10 10
Device Markings/Labelling Problem 8 8
Failure to Power Up 7 7
Activation, Positioning or Separation Problem 6 6
Application Program Freezes, Becomes Nonfunctional 6 6
Material Protrusion/Extrusion 5 5
Patient-Device Incompatibility 5 5
Defective Device 4 4
Detachment of Device or Device Component 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Device Contaminated During Manufacture or Shipping 4 4
Device Dislodged or Dislocated 4 4
No Apparent Adverse Event 3 3
Circuit Failure 3 3
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 Split, Cut or Torn 2 2
Intermittent Loss of Power 1 1
Unexpected Shutdown 1 1
Audible Prompt/Feedback Problem 1 1
Activation Failure 1 1
Power Problem 1 1
Problem with Software Installation 1 1
Temperature Problem 1 1
Expulsion 1 1
Failure of Device to Self-Test 1 1
Battery Problem: Low Impedance 1 1
Compatibility Problem 1 1
Output Problem 1 1
Intermittent Communication Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6163 6163
Pain 5017 5017
Insufficient Information 4792 4792
Incontinence 3064 3064
Electric Shock 2537 2537
Discomfort 2370 2370
No Known Impact Or Consequence To Patient 2224 2224
Therapeutic Effects, Unexpected 2221 2221
Urinary Retention 1934 1934
Urinary Frequency 1554 1554
Therapeutic Response, Decreased 1513 1513
Undesired Nerve Stimulation 1409 1409
Unspecified Infection 1387 1387
Complaint, Ill-Defined 1284 1284
Burning Sensation 757 757
Device Embedded In Tissue or Plaque 694 694
Micturition Urgency 646 646
Device Overstimulation of Tissue 588 588
Sleep Dysfunction 443 443
Hemorrhage/Bleeding 392 392
Constipation 382 382
Ambulation Difficulties 377 377
Urinary Tract Infection 359 359
Diarrhea 321 321
Urinary Incontinence 305 305
Failure of Implant 238 238
Cramp(s) /Muscle Spasm(s) 217 217
Swelling/ Edema 216 216
Malaise 209 209
Numbness 209 209
Dysuria 197 197
Fluid Discharge 184 184
Pocket Erosion 175 175
Erythema 172 172
Paresthesia 166 166
Itching Sensation 144 144
Wound Dehiscence 137 137
Weight Changes 121 121
Scar Tissue 114 114
Nausea 111 111
Abdominal Pain 111 111
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 103 103
Bruise/Contusion 102 102
Swelling 100 100
Impaired Healing 85 85
Bacterial Infection 84 84
Inflammation 84 84
Nerve Damage 83 83
Post Operative Wound Infection 83 83
Fever 81 81
Hypersensitivity/Allergic reaction 80 80
Fecal Incontinence 79 79
Tingling 75 75
Muscle Spasm(s) 73 73
Erosion 72 72
Fall 70 70
Skin Inflammation/ Irritation 66 66
Headache 64 64
Purulent Discharge 63 63
Foreign Body Reaction 59 59
Dizziness 58 58
Fatigue 57 57
Flatus 55 55
Hematoma 54 54
Distress 53 53
Twitching 51 51
Anxiety 50 50
Vomiting 49 49
Muscle Weakness 49 49
Rash 47 47
Implant Pain 47 47
Abdominal Distention 46 46
Cramp(s) 45 45
Muscular Rigidity 45 45
Shaking/Tremors 44 44
Loss of consciousness 36 36
Hematuria 33 33
Abscess 30 30
High Blood Pressure/ Hypertension 29 29
Cognitive Changes 29 29
Foreign Body In Patient 28 28
Sepsis 28 28
Seroma 27 27
Dehydration 26 26
Confusion/ Disorientation 26 26
Irritation 25 25
Depression 23 23
Paralysis 21 21
Skin Irritation 20 20
Unspecified Tissue Injury 20 20
No Code Available 19 19
Abdominal Cramps 19 19
Intraoperative Pain 18 18
Tissue Breakdown 18 18
Chills 18 18
Cellulitis 18 18
Burn(s) 17 17
Neuropathy 16 16
Irritability 16 16
Tachycardia 15 15

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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