| Device Type ID | 1659 |
| Device Name | Implant, Cochlear |
| Review Panel | Ear Nose & Throat |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MCM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1659 |
| Device | Implant, Cochlear |
| Product Code | MCM |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Appropriate Term/Code Not Available | 3124 |
Device Operates Differently Than Expected | 2857 |
Receiver Stimulator Unit | 911 |
Output Problem | 889 |
No Device Output | 811 |
Migration Or Expulsion Of Device | 413 |
Electrode | 402 |
Insufficient Information | 376 |
Adverse Event Without Identified Device Or Use Problem | 370 |
Extrusion | 341 |
Magnet | 256 |
Device Stops Intermittently | 166 |
Migration | 153 |
Circuit Failure | 65 |
Device Dislodged Or Dislocated | 59 |
Impedance Problem | 51 |
Expulsion | 45 |
Fluid Leak | 41 |
High Impedance | 37 |
Battery Problem | 35 |
Communication Or Transmission Problem | 32 |
Lithium Iodide Battery | 28 |
Improper Or Incorrect Procedure Or Method | 25 |
Device Inoperable | 24 |
Folded | 22 |
Malposition Of Device | 14 |
Lock | 14 |
Device Operational Issue | 12 |
Noise, Audible | 11 |
Intermittent Loss Of Power | 11 |
Device Issue | 10 |
Unintended Movement | 10 |
Therapeutic Or Diagnostic Output Failure | 10 |
Device Appears To Trigger Rejection | 9 |
Locking Mechanism | 9 |
Missing Value Reason | 9 |
Device Slipped | 9 |
Break | 8 |
Product Quality Problem | 7 |
Leak / Splash | 6 |
Electrical Shorting | 6 |
Material Protrusion / Extrusion | 5 |
Difficult To Insert | 5 |
Patient-Device Incompatibility | 5 |
Device Displays Incorrect Message | 5 |
Connection Problem | 4 |
Programming Issue | 4 |
Positioning Problem | 4 |
Device Handling Problem | 4 |
Operating System Version Or Upgrade Problem | 3 |
Mechanical Problem | 3 |
Device Component Or Accessory | 3 |
Human-Device Interface Problem | 3 |
Inappropriate Shock | 3 |
Electrical Lead | 2 |
Improper Device Output | 2 |
Failure To Sense | 2 |
Fire | 2 |
Biofilm Coating In Device | 2 |
Output Below Specifications | 2 |
Crack | 2 |
Overheating Of Device | 2 |
Scratched Material | 2 |
Mechanics Altered | 2 |
Fitting Problem | 2 |
Loss Of Osseointegration | 1 |
Pressure Problem | 1 |
Unintended Collision | 1 |
Loss Of Threshold | 1 |
Electromagnetic Interference | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Kinked | 1 |
Moisture Damage | 1 |
Pacing Problem | 1 |
No Audible Prompt / Feedback | 1 |
Device Damaged Prior To Use | 1 |
Device Markings / Labelling Problem | 1 |
Housing | 1 |
Disconnection | 1 |
Device Or Device Fragments Location Unknown | 1 |
Nonstandard Device | 1 |
Electromagnetic Compatibility Problem | 1 |
High Readings | 1 |
Intermittent Continuity | 1 |
Electrical /Electronic Property Problem | 1 |
Speech Processor | 1 |
Tip | 1 |
Screw | 1 |
Degraded | 1 |
Use Of Device Problem | 1 |
Intermittent Shock | 1 |
Component Missing | 1 |
Bent | 1 |
Battery Charger | 1 |
Power Problem | 1 |
Handpiece | 1 |
Vibration | 1 |
Electro-Static Discharge | 1 |
Low Impedance | 1 |
Battery | 1 |
| Total Device Problems | 11796 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cochlear Americas Inc. | II | Jul-20-2015 |