| Device Type ID | 783 |
| Device Name | Pulse-generator, Pacemaker, External |
| Regulation Description | External 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 | 510(k) |
| CFR Regulation Number | 870.3600 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | DTE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 783 |
| Device | Pulse-generator, Pacemaker, External |
| Product Code | DTE |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | External Pacemaker Pulse Generator. |
| CFR Regulation Number | 870.3600 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
MEDTRONIC, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
| Device Problems | |
|---|---|
Connection Problem | 997 |
Mechanical Problem | 259 |
Device Displays Incorrect Message | 172 |
No Display / Image | 126 |
Output Problem | 94 |
Calibration Problem | 92 |
Break | 84 |
Electrical /Electronic Property Problem | 76 |
No Device Output | 62 |
Component Missing | 56 |
Failure To Power Up | 46 |
Power Problem | 44 |
Device Sensing Problem | 43 |
Device Operates Differently Than Expected | 34 |
Display Or Visual Feedback Problem | 32 |
Nonstandard Device | 25 |
Failure To Sense | 23 |
Material Integrity Problem | 23 |
Failure To Capture | 18 |
Contamination During Use | 18 |
Crack | 18 |
Loose Or Intermittent Connection | 18 |
Under-Sensing | 18 |
Computer Software Problem | 17 |
Device Difficult To Program Or Calibrate | 15 |
Degraded | 13 |
Pacing Problem | 13 |
Corroded | 10 |
Moisture Damage | 9 |
Pacing Intermittently | 9 |
Device Contamination With Chemical Or Other Material | 8 |
Inadequate User Interface | 8 |
Battery Problem | 8 |
Signal Artifact | 7 |
Use Of Device Problem | 7 |
Intermittent Capture | 7 |
Unexpected Shutdown | 7 |
Difficult To Insert | 5 |
Output Below Specifications | 5 |
Electronic Property Issue | 5 |
Over-Sensing | 5 |
Operating System Becomes Nonfunctional | 5 |
Blocked Connection | 4 |
Failure To Shut Off | 3 |
Data Problem | 3 |
No Pacing | 3 |
Output Above Specifications | 3 |
Device Dislodged Or Dislocated | 2 |
Application Interface Becomes Non-Functional Or Program Exits Abnormally | 2 |
Insufficient Information | 2 |
Detachment Of Device Or Device Component | 2 |
Low Battery | 2 |
Impedance Problem | 2 |
Computer Operating System Problem | 2 |
Sensing Intermittently | 2 |
Failure Of Device To Self-Test | 2 |
Detachment Of Device Component | 1 |
Sticking | 1 |
Reset Problem | 1 |
Operating System Version Or Upgrade Problem | 1 |
Device Handling Problem | 1 |
Patient Device Interaction Problem | 1 |
Positioning Problem | 1 |
Connector | 1 |
Noise, Audible | 1 |
Collapse | 1 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 1 |
Cut In Material | 1 |
Failure To Align | 1 |
Display Difficult To Read | 1 |
Failure To Read Input Signal | 1 |
Device Inoperable | 1 |
Increased Sensitivity | 1 |
Compatibility Problem | 1 |
Pacing Inadequately | 1 |
Device Operational Issue | 1 |
Inadequate Lighting | 1 |
Appropriate Term/Code Not Available | 1 |
Unknown (for Use When The Device Problem Is Not Known) | 1 |
Deformation Due To Compressive Stress | 1 |
Capturing Problem | 1 |
Device Difficult To Setup Or Prepare | 1 |
Premature Discharge Of Battery | 1 |
Component Misassembled | 1 |
Application Program Freezes, Becomes Nonfunctional | 1 |
Contamination / Decontamination Problem | 1 |
| Total Device Problems | 2605 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Medtronic Inc. Cardiac Rhythm Disease Management | II | Mar-31-2015 |
| 2 | Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF) | II | Jun-29-2018 |