| Device Type ID | 830 |
| Device Name | Implantable Pacemaker Pulse-generator |
| 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 | DXY |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 830 |
| Device | Implantable Pacemaker Pulse-generator |
| Product Code | DXY |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Implantable Pacemaker Pulse Generator. |
| CFR Regulation Number | 870.3610 [🔎] |
| Device Problems | |
|---|---|
Pacemaker Found In Back-Up Mode | 1515 |
Adverse Event Without Identified Device Or Use Problem | 1121 |
Over-Sensing | 639 |
Device Dislodged Or Dislocated | 629 |
Device Operates Differently Than Expected | 581 |
Failure To Capture | 408 |
High Capture Threshold | 291 |
Signal Artifact | 279 |
Premature Discharge Of Battery | 218 |
High Impedance | 212 |
Failure To Interrogate | 207 |
Device Displays Incorrect Message | 165 |
Screw | 151 |
Low Impedance | 151 |
Pacing Problem | 140 |
Device Sensing Problem | 139 |
Under-Sensing | 138 |
Failure To Sense | 137 |
Capturing Problem | 124 |
Fracture | 122 |
Break | 120 |
Appropriate Term/Code Not Available | 106 |
Inappropriate Shock | 89 |
Mechanical Problem | 85 |
Connection Problem | 84 |
Impedance Problem | 83 |
Output Problem | 78 |
Telemetry Discrepancy | 74 |
Premature Elective Replacement Indicator | 70 |
Intermittent Capture | 63 |
Insulation | 55 |
Decreased Sensitivity | 54 |
Difficult To Insert | 41 |
No Device Output | 35 |
Loss Of Data | 32 |
Invalid Sensing | 30 |
Retraction Problem | 30 |
Unstable Capture Threshold | 29 |
Data Problem | 28 |
Misconnection | 28 |
Battery Problem | 27 |
Communication Or Transmission Problem | 26 |
No Pacing | 26 |
Helifix Coil | 26 |
Ambient Noise Problem | 26 |
Incorrect Measurement | 25 |
Positioning Problem | 24 |
Stylet | 23 |
Positioning Failure | 23 |
Material Integrity Problem | 23 |
Inappropriate Or Unexpected Reset | 22 |
Low Sensing Threshold | 22 |
Insufficient Information | 20 |
Difficult To Interrogate | 20 |
Difficult To Remove | 20 |
Activation, Positioning Or Separation Problem | 18 |
Sensing Intermittently | 16 |
Reset Problem | 16 |
Electromagnetic Interference | 15 |
Unable To Obtain Readings | 15 |
Cautery | 14 |
Header | 13 |
Migration Or Expulsion Of Device | 12 |
Electronic Property Issue | 11 |
Protective Measures Problem | 10 |
Fitting Problem | 10 |
Defibrillation Problem | 9 |
Battery Impedance Issue | 9 |
Pacing Inadequately | 9 |
Electrical /Electronic Property Problem | 9 |
Failure To Transmit Record | 8 |
Loose Or Intermittent Connection | 8 |
Nonstandard Device | 7 |
Device Contamination With Chemical Or Other Material | 7 |
Material Deformation | 7 |
Battery Problem: High Impedance | 7 |
Pocket Stimulation | 7 |
Incorrect Device Or Component Shipped | 6 |
Cut In Material | 6 |
Lead | 6 |
Premature End-of-Life Indicator | 5 |
Device-Device Incompatibility | 5 |
Pacing Intermittently | 5 |
Wireless Communication Problem | 5 |
Application Interface Becomes Non-Functional Or Program Exits Abnormally | 5 |
Material Twisted / Bent | 5 |
Degraded | 5 |
Programming Issue | 4 |
Missing Test Results | 4 |
Bent | 4 |
Device Handling Problem | 4 |
Separation Failure | 4 |
Detachment Of Device Component | 4 |
Incorrect Interpretation Of Signal | 3 |
Kinked | 3 |
Connector | 3 |
Shelf Life Exceeded | 3 |
Crack | 3 |
Display Or Visual Feedback Problem | 3 |
Device Expiration Issue | 3 |
| Total Device Problems | 9269 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | St Jude Medical Inc. | II | Jun-12-2018 |