| Device Type ID | 862 |
| Device Name | Electrode, Pacemaker, Temporary |
| Regulation Description | Cardiovascular Permanent Or Temporary Pacemaker Electrode. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Implantable Electrophysical Devices Branch (IEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.3680 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LDF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 862 |
| Device | Electrode, Pacemaker, Temporary |
| Product Code | LDF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiovascular Permanent Or Temporary Pacemaker Electrode. |
| CFR Regulation Number | 870.3680 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABBOTT LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
EDWARDS LIFESCIENCES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EDWARDS LIFESCIENCES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ETHICON | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ETHICON, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
ST. JUDE MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Pacing Problem | 97 |
Break | 22 |
Adverse Event Without Identified Device Or Use Problem | 15 |
Appropriate Term/Code Not Available | 11 |
Detachment Of Device Component | 10 |
Material Rupture | 7 |
Material Integrity Problem | 7 |
Inflation Problem | 5 |
No Pacing | 5 |
Connection Problem | 5 |
Fracture | 4 |
Over-Sensing | 4 |
Tear, Rip Or Hole In Device Packaging | 3 |
Device Operates Differently Than Expected | 3 |
Device Dislodged Or Dislocated | 3 |
Fluid Leak | 3 |
Detachment Of Device Or Device Component | 3 |
Insufficient Information | 3 |
Ambient Noise Problem | 2 |
Disconnection | 2 |
Entrapment Of Device | 2 |
Leak / Splash | 2 |
Fitting Problem | 2 |
Deflation Problem | 2 |
Balloon | 2 |
High Impedance | 2 |
Human-Device Interface Problem | 2 |
Migration Or Expulsion Of Device | 2 |
Pacing Inadequately | 1 |
Failure To Sense | 1 |
Physical Resistance | 1 |
Bent | 1 |
Device Sensing Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Low Impedance | 1 |
Failure To Adhere Or Bond | 1 |
Failure To Capture | 1 |
Unraveled Material | 1 |
Circuit Failure | 1 |
Electrical /Electronic Property Problem | 1 |
Incorrect Measurement | 1 |
Component Missing | 1 |
Capturing Problem | 1 |
Activation, Positioning Or Separation Problem | 1 |
Catheter | 1 |
Electrode | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Sticking | 1 |
Material Fragmentation | 1 |
Material Separation | 1 |
Incomplete Or Missing Packaging | 1 |
High Capture Threshold | 1 |
Difficult To Insert | 1 |
Loose Or Intermittent Connection | 1 |
Inadequate User Interface | 1 |
Nonstandard Device | 1 |
No Device Output | 1 |
Failure To Unfold Or Unwrap | 1 |
| Total Device Problems | 260 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Medtronic Inc., Cardiac Rhythm And Heart Failure | II | Sep-19-2016 |
| 2 | Oscor, Inc. | I | Nov-08-2018 |