| Device Type ID | 894 |
| Device Name | Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) |
| Regulation Description | Medical Magnetic Tape Recorder. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.2800 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MXC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 894 |
| Device | Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) |
| Product Code | MXC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Medical Magnetic Tape Recorder. |
| CFR Regulation Number | 870.2800 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABBOTT | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ABBOTT LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ST. JUDE MEDICAL (ABBOTT LABORATORIES) | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ST. JUDE MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Under-Sensing | 1367 |
Failure To Interrogate | 201 |
Data Problem | 191 |
Over-Sensing | 167 |
Pacemaker Found In Back-Up Mode | 126 |
Device Displays Incorrect Message | 111 |
Adverse Event Without Identified Device Or Use Problem | 109 |
Signal Artifact | 80 |
Device Operates Differently Than Expected | 69 |
Failure To Sense | 65 |
Premature Discharge Of Battery | 57 |
Inappropriate Or Unexpected Reset | 53 |
Sensing Intermittently | 40 |
Wireless Communication Problem | 38 |
Communication Or Transmission Problem | 38 |
Device Sensing Problem | 36 |
Difficult To Interrogate | 30 |
Incorrect Interpretation Of Signal | 27 |
Migration Or Expulsion Of Device | 22 |
Decreased Sensitivity | 16 |
Telemetry Discrepancy | 16 |
Premature Elective Replacement Indicator | 14 |
Appropriate Term/Code Not Available | 13 |
Migration | 10 |
Incorrect Measurement | 8 |
Electromagnetic Interference | 7 |
Low Sensing Threshold | 5 |
Break | 4 |
Image Display Error / Artifact | 4 |
Use Of Device Problem | 4 |
Header | 4 |
Battery Problem | 4 |
Failure To Capture | 3 |
Device Difficult To Program Or Calibrate | 3 |
Connection Problem | 3 |
Cut In Material | 3 |
Detachment Of Device Or Device Component | 2 |
Loose Or Intermittent Connection | 2 |
Detachment Of Device Component | 2 |
Out-Of-Box Failure | 2 |
Device Dislodged Or Dislocated | 2 |
Interrogation Problem | 2 |
Missing Test Results | 1 |
Year 2000 (Y2K) Related Problem | 1 |
Application Program Version Or Upgrade Problem | 1 |
Failure To Read Input Signal | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Loss Of Data | 1 |
Issue With Displayed Error Message | 1 |
Power Problem | 1 |
Intermittent Communication Failure | 1 |
Failure To Transmit Record | 1 |
Installation-Related Problem | 1 |
False Device Output | 1 |
Material Fragmentation | 1 |
Reset Problem | 1 |
Failure To Analyze Signal | 1 |
Device Damaged Prior To Use | 1 |
Dull, Blunt | 1 |
Positioning Problem | 1 |
Connector | 1 |
Computer Software Problem | 1 |
Temperature Problem | 1 |
Cautery | 1 |
Insufficient Information | 1 |
| Total Device Problems | 2983 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | St Jude Medical Inc. | II | Jun-29-2018 |