Definition: To Treat Bradycardia (slow Heartbeats) With Right Atrial And/or Right Ventricular Pacing Therapy As Necessary.
| Device Type ID | 972 |
| Device Name | Leadless Pacemaker |
| Physical State | TBD |
| Technical Method | TBD |
| Target Area | TBD |
| Regulation Description | Implantable Pacemaker Pulse Generator. |
| 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 | PMA |
| CFR Regulation Number | 870.3610 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | PNJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 972 |
| Device | Leadless Pacemaker |
| Product Code | PNJ |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Implantable Pacemaker Pulse Generator. |
| CFR Regulation Number | 870.3610 [🔎] |
| Device Problems | |
|---|---|
High Capture Threshold | 276 |
Capturing Problem | 234 |
Adverse Event Without Identified Device Or Use Problem | 219 |
Failure To Capture | 151 |
Positioning Problem | 108 |
Pacing Problem | 90 |
Device Dislodged Or Dislocated | 82 |
Appropriate Term/Code Not Available | 76 |
Use Of Device Problem | 53 |
Premature Discharge Of Battery | 40 |
Under-Sensing | 40 |
Impedance Problem | 35 |
Device Operates Differently Than Expected | 33 |
Unstable Capture Threshold | 32 |
Material Integrity Problem | 30 |
Decreased Sensitivity | 28 |
High Impedance | 27 |
Device Sensing Problem | 26 |
Intermittent Capture | 21 |
Battery Problem | 14 |
Leak / Splash | 13 |
Mechanical Problem | 12 |
Communication Or Transmission Problem | 12 |
Over-Sensing | 11 |
Electrical /Electronic Property Problem | 11 |
Output Problem | 11 |
Failure To Interrogate | 10 |
Difficult To Remove | 9 |
Kinked | 9 |
Reset Problem | 9 |
Failure To Advance | 8 |
Activation, Positioning Or Separation Problem | 8 |
Difficult To Flush | 7 |
Incorrect Measurement | 5 |
Low Impedance | 5 |
Migration Or Expulsion Of Device | 4 |
Deformation Due To Compressive Stress | 4 |
Inappropriate Or Unexpected Reset | 4 |
Unable To Obtain Readings | 4 |
Break | 3 |
Device Expiration Issue | 3 |
Insufficient Information | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Coagulation In Device Or Device Ingredient | 2 |
Fracture | 2 |
Data Problem | 2 |
Energy Output Problem | 1 |
Bent | 1 |
Failure To Sense | 1 |
Material Twisted / Bent | 1 |
Device Displays Incorrect Message | 1 |
Output Above Specifications | 1 |
Invalid Sensing | 1 |
No Apparent Adverse Event | 1 |
Signal Artifact | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Material Deformation | 1 |
Physical Resistance / Sticking | 1 |
Battery Problem: High Impedance | 1 |
Protective Measures Problem | 1 |
Device Handling Problem | 1 |
Electromagnetic Interference | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Material Erosion | 1 |
| Total Device Problems | 1805 |