Definition: Pacemaker/ICD/CRT Non-implanted Components Provide Programming, Interrogation, Printing, Remote Monitoring, And Communication Between The Pulse Generator And The Health Care Provider.
| Device Type ID | 1072 |
| Device Name | Pacemaker/icd/crt Non-implanted Components |
| Physical State | Pacemaker/ICD/CRT Non-implanted Components Can Be Separate Pieces Or Integrated And Usually Include Housings, Electronics, Processors, Software, Connectors, And Cables. |
| Technical Method | Pacemaker/ICD/CRT Non-implanted Components Transmit Data From The Implanted Device To The Health Care Provider Using Telemetry Download, And Direct Or Remote Transmission. |
| Target Area | Pacemaker/ICD/CRT Devices Are Intended To Provide Therapy To The Heart. The Non-implanted Components Support The Implanted Devices. |
| 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 | OSR |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1072 |
| Device | Pacemaker/icd/crt Non-implanted Components |
| Product Code | OSR |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 65 |
No Apparent Adverse Event | 9 |
Communication Or Transmission Problem | 8 |
Pacing Problem | 8 |
Defective Device | 7 |
Inadequate User Interface | 7 |
Ambient Noise Problem | 4 |
Wireless Communication Problem | 4 |
Application Program Problem | 3 |
Computer Operating System Problem | 3 |
Device Packaging Compromised | 3 |
Device Operational Issue | 3 |
Over-Sensing | 3 |
Inappropriate Shock | 3 |
Power Problem | 3 |
Device Displays Incorrect Message | 3 |
Adverse Event Without Identified Device Or Use Problem | 2 |
High Impedance | 2 |
Capturing Problem | 2 |
Under-Sensing | 2 |
Detachment Of Device Component | 2 |
Computer Software Problem | 2 |
Device Alarm System | 1 |
Packaging Problem | 1 |
No Device Output | 1 |
Overheating Of Device | 1 |
Failure To Power Up | 1 |
Appropriate Term/Code Not Available | 1 |
Activation Problem | 1 |
Failure To Interrogate | 1 |
Electrical /Electronic Property Problem | 1 |
Device Stops Intermittently | 1 |
Device Inoperable | 1 |
Low Impedance | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Device Sensing Problem | 1 |
Issue With Displayed Error Message | 1 |
Material Integrity Problem | 1 |
Fire | 1 |
| Total Device Problems | 165 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF) | II | Feb-16-2019 |
| 2 | Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF) | II | Feb-02-2019 |
| 3 | Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF) | II | Nov-08-2018 |
| 4 | St Jude Medical Inc. | II | Jun-29-2018 |
| 5 | St Jude Medical Inc. | II | Jun-12-2018 |