Definition: PMAs To Be Filed By 12/26/96 (61 FR 50707 (9/27/96))
| Device Type ID | 1716 |
| Device Name | Stimulator, Electrical, Implantable, For Incontinence |
| Regulation Description | Implanted Electrical Urinary Continence Device. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | PMA |
| CFR Regulation Number | 876.5270 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | EZW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1716 |
| Device | Stimulator, Electrical, Implantable, For Incontinence |
| Product Code | EZW |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Implanted Electrical Urinary Continence Device. |
| CFR Regulation Number | 876.5270 [🔎] |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 8060 |
Adverse Event Without Identified Device Or Use Problem | 4371 |
Failure To Deliver Energy | 4235 |
Migration Or Expulsion Of Device | 2547 |
Unintended Collision | 1773 |
Inappropriate Shock | 1647 |
Device Displays Incorrect Message | 1568 |
Therapy Delivered To Incorrect Body Area | 1314 |
Break | 1165 |
Electromagnetic Compatibility Problem | 1117 |
Insufficient Information | 1098 |
Communication Or Transmission Problem | 935 |
High Impedance | 903 |
Electromagnetic Interference | 808 |
Intermittent Continuity | 697 |
Energy Output Problem | 666 |
Failure To Interrogate | 599 |
Battery Problem | 593 |
Malposition Of Device | 529 |
Low Battery | 512 |
Device Or Device Fragments Location Unknown | 434 |
Connection Problem | 402 |
Overheating Of Device | 361 |
Unexpected Therapeutic Results | 348 |
Impedance Problem | 336 |
Positioning Problem | 262 |
Pocket Stimulation | 251 |
Unstable | 245 |
Premature Discharge Of Battery | 230 |
Patient Device Interaction Problem | 230 |
Material Deformation | 144 |
Disconnection | 136 |
Low Impedance | 136 |
Energy Output To Patient Tissue Incorrect | 129 |
No Device Output | 112 |
Environmental Compatibility Problem | 97 |
Improper Device Output | 93 |
Inadequate Instructions For Non-Healthcare Professional | 86 |
Device Contamination With Chemical Or Other Material | 80 |
Difficult To Remove | 74 |
Loss Of Data | 67 |
Human-Device Interface Problem | 64 |
Shipping Damage Or Problem | 62 |
Display Or Visual Feedback Problem | 62 |
Data Problem | 57 |
Peeled / Delaminated | 53 |
Unable To Obtain Readings | 45 |
Ambient Noise Problem | 32 |
Labelling, Instructions For Use Or Training Problem | 30 |
Vibration | 30 |
Device Difficult To Program Or Calibrate | 29 |
Failure To Power Up | 27 |
Electro-Static Discharge | 21 |
Therapeutic Or Diagnostic Output Failure | 19 |
Shelf Life Exceeded | 16 |
Stretched | 16 |
Degraded | 15 |
Bent | 14 |
Noise, Audible | 13 |
Inadequacy Of Device Shape And/or Size | 13 |
Difficult To Insert | 12 |
Material Integrity Problem | 12 |
Component Missing | 10 |
Use Of Device Problem | 9 |
Improper Or Incorrect Procedure Or Method | 7 |
Material Twisted / Bent | 7 |
Contamination During Use | 6 |
Inadequate Or Insufficient Training | 5 |
Unsealed Device Packaging | 5 |
Computer Software Problem | 4 |
Manufacturing, Packaging Or Shipping Problem | 4 |
Material Perforation | 4 |
Appropriate Term/Code Not Available | 4 |
Charging Problem | 3 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 3 |
Mechanical Problem | 3 |
Device Markings / Labelling Problem | 3 |
Application Program Problem | 2 |
Incorrect Device Or Component Shipped | 2 |
Inadequate Instructions For Healthcare Professional | 2 |
Unauthorized Access To Computer System | 2 |
Low Readings | 1 |
Compatibility Problem | 1 |
Corroded | 1 |
Operating System Becomes Nonfunctional | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Fitting Problem | 1 |
Folded | 1 |
Component Incompatible | 1 |
Use Of Incorrect Control Settings | 1 |
Installation-Related Problem | 1 |
Entrapment Of Device | 1 |
| Total Device Problems | 40128 |