| Device Type ID | 1037 |
| Device Name | Defibrillator, Implantable, Dual-chamber |
| 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 | MRM |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1037 |
| Device | Defibrillator, Implantable, Dual-chamber |
| Product Code | MRM |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Over-Sensing | 267 |
Adverse Event Without Identified Device Or Use Problem | 217 |
Inappropriate Shock | 137 |
Failure To Interrogate | 97 |
Premature Discharge Of Battery | 62 |
Device Operates Differently Than Expected | 62 |
Premature End-of-Life Indicator | 59 |
Premature Elective Replacement Indicator | 57 |
Pacemaker Found In Back-Up Mode | 54 |
Communication Or Transmission Problem | 44 |
Device Displays Incorrect Message | 43 |
Ambient Noise Problem | 42 |
High Impedance | 37 |
Application Interface Becomes Non-Functional Or Program Exits Abnormally | 34 |
Display Or Visual Feedback Problem | 29 |
Battery Problem | 27 |
Low Impedance | 22 |
Insufficient Information | 22 |
Inappropriate Or Unexpected Reset | 21 |
Wireless Communication Problem | 14 |
Reset Problem | 13 |
Defibrillation Problem | 13 |
Failure To Transmit Record | 12 |
Failure To Capture | 12 |
Connection Problem | 11 |
Unexpected Therapeutic Results | 10 |
Impedance Problem | 10 |
High Capture Threshold | 9 |
Under-Sensing | 9 |
Data Problem | 9 |
Low Battery | 8 |
Difficult To Interrogate | 7 |
Operating System Becomes Nonfunctional | 7 |
Programming Issue | 7 |
Fracture | 6 |
No Pacing | 6 |
Appropriate Term/Code Not Available | 6 |
Pacing Problem | 6 |
User Interface | 6 |
Lead | 6 |
Failure To Power Up | 6 |
Unexpected Shutdown | 6 |
Telemetry Discrepancy | 5 |
Unable To Obtain Readings | 5 |
Failure To Deliver Shock | 5 |
No Apparent Adverse Event | 5 |
No Display / Image | 5 |
Pacing Inadequately | 5 |
Device Sensing Problem | 5 |
Issue With Displayed Error Message | 5 |
Device Operational Issue | 4 |
Therapeutic Or Diagnostic Output Failure | 4 |
Electrical /Electronic Property Problem | 4 |
Erratic Or Intermittent Display | 4 |
Intermittent Capture | 3 |
Delayed Charge Time | 3 |
Loose Or Intermittent Connection | 3 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 3 |
Incorrect Or Inadequate Test Results | 3 |
Operating System Version Or Upgrade Problem | 3 |
Unstable Capture Threshold | 3 |
Signal Artifact | 3 |
Loss Of Data | 3 |
Charging Problem | 2 |
Material Discolored | 2 |
Missing Test Results | 2 |
Interrogation Problem | 2 |
Application Program Version Or Upgrade Problem | 2 |
Migration Or Expulsion Of Device | 2 |
Application Program Freezes, Becomes Nonfunctional | 2 |
Intermittent Communication Failure | 2 |
Sensing Intermittently | 2 |
Plug | 2 |
Nonstandard Device | 2 |
No Device Output | 2 |
Display | 2 |
Noise, Audible | 2 |
Disconnection | 2 |
Connector | 1 |
Material Erosion | 1 |
Computer Software Problem | 1 |
Failure To Conduct | 1 |
Malposition Of Device | 1 |
Failure To Analyze Signal | 1 |
Pacing Asynchronously | 1 |
Battery Impedance Issue | 1 |
Break | 1 |
Mechanical Problem | 1 |
Premature Activation | 1 |
Calibration Problem | 1 |
Failure To Back-Up | 1 |
Failure To Convert Rhythm | 1 |
Fitting Problem | 1 |
Patient Data Problem | 1 |
Incomplete Or Missing Packaging | 1 |
Mechanical Jam | 1 |
Incorrect Interpretation Of Signal | 1 |
Lead Conductor | 1 |
Electromagnetic Interference | 1 |
Failure To Deliver Energy | 1 |
| Total Device Problems | 1667 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Sorin Group Italia SRL - CRF | II | Sep-28-2017 |
| 2 | Sorin Group Italia SRL - CRF | II | May-18-2017 |