| Device Type ID | 1026 |
| Device Name | Device, Removal, Pacemaker Electrode, Percutaneous |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Implantable Electrophysical Devices Branch (IEDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MFA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1026 |
| Device | Device, Removal, Pacemaker Electrode, Percutaneous |
| Product Code | MFA |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 69 |
Hole In Material | 2 |
Material Separation | 2 |
Break | 2 |
Crack | 2 |
Insufficient Information | 2 |
Thermal Decomposition Of Device | 1 |
Material Protrusion / Extrusion | 1 |
Positioning Failure | 1 |
Material Deformation | 1 |
High Impedance | 1 |
Extrusion | 1 |
Smoking | 1 |
Appropriate Term/Code Not Available | 1 |
Failure To Adhere Or Bond | 1 |
Bent | 1 |
Fracture | 1 |
Physical Resistance | 1 |
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 92 |