Definition: Intended As A Permanent Implant To Deliver Pacing Pulses And Other Pacing Therapies Through Pacing Leads Implanted In The Heart.
Device Type ID | 1060 |
Device Name | Pulse Generator, Permanent, Implantable |
Physical State | A Hermetically Sealed Outer Can (usually Metallic) Houses Electronic Circuitry And Allows For Connection To Pacing Leads (electrodes). |
Technical Method | Used As Part Of A Pacing System That Consists Of A Pulse Generator And A Lead, And Which May Also Require An External Pacemaker Programmer. |
Target Area | Implanted In The Chest Or Abdomen, And Makes Contact With Cardiac Tissue Via Pacing Leads. |
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 | NVZ |
GMP Exempt | No |
Summary MR | Ineligible |
Implanted Device | Yes |
Life Support Device | Yes |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1060 |
Device | Pulse Generator, Permanent, Implantable |
Product Code | NVZ |
FDA Device Classification | Class 3 Medical Device |
Device Problems | |
---|---|
Adverse Event Without Identified Device Or Use Problem | 2269 |
Battery Problem | 1852 |
Premature Discharge Of Battery | 1827 |
Pacing Problem | 1261 |
Mechanical Problem | 782 |
Over-Sensing | 719 |
Appropriate Term/Code Not Available | 707 |
Failure To Interrogate | 585 |
Failure To Capture | 326 |
Inappropriate Or Unexpected Reset | 297 |
Unable To Obtain Readings | 295 |
Incorrect Measurement | 283 |
High Impedance | 234 |
Pacemaker Found In Back-Up Mode | 188 |
Communication Or Transmission Problem | 186 |
Inappropriate Shock | 166 |
Device Operates Differently Than Expected | 160 |
Device Sensing Problem | 159 |
Migration Or Expulsion Of Device | 153 |
Premature Elective Replacement Indicator | 152 |
Under-Sensing | 125 |
Signal Artifact | 119 |
Reset Problem | 115 |
Output Problem | 109 |
Overheating Of Device | 103 |
High Capture Threshold | 103 |
Capturing Problem | 97 |
Battery Problem: High Impedance | 92 |
Device Displays Incorrect Message | 91 |
Misconnection | 91 |
Data Problem | 87 |
No Pacing | 83 |
Insufficient Information | 82 |
Impedance Problem | 68 |
Break | 64 |
Use Of Device Problem | 63 |
False Positive Result | 53 |
Low Impedance | 52 |
Delayed Charge Time | 51 |
Incorrect Interpretation Of Signal | 45 |
Connection Problem | 43 |
Electrical /Electronic Property Problem | 39 |
Nonstandard Device | 38 |
Intermittent Capture | 37 |
Electromagnetic Interference | 37 |
Battery Impedance Issue | 36 |
Premature End-of-Life Indicator | 32 |
Loose Or Intermittent Connection | 31 |
Invalid Sensing | 30 |
Telemetry Discrepancy | 29 |
Pacing Inadequately | 28 |
Protective Measures Problem | 27 |
Missing Test Results | 24 |
Screw | 24 |
Difficult To Interrogate | 23 |
Defibrillation Problem | 23 |
Ambient Noise Problem | 23 |
Failure To Deliver Shock | 23 |
Loss Of Data | 20 |
Failure To Charge | 19 |
Device Emits Odor | 18 |
Device-Device Incompatibility | 18 |
Pocket Stimulation | 17 |
Failure To Sense | 17 |
False Alarm | 16 |
Output Above Specifications | 16 |
Pacing Intermittently | 16 |
Display Or Visual Feedback Problem | 16 |
Unstable Capture Threshold | 15 |
Decreased Sensitivity | 15 |
Component Missing | 15 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 14 |
Positioning Problem | 14 |
Incorrect Or Inadequate Test Results | 13 |
Power Problem | 13 |
Device Contamination With Body Fluid | 12 |
Device Expiration Issue | 12 |
Defective Alarm | 10 |
Wireless Communication Problem | 10 |
Programming Issue | 10 |
Device Dislodged Or Dislocated | 10 |
Failure To Transmit Record | 10 |
Device Contamination With Chemical Or Other Material | 9 |
Incorrect Device Or Component Shipped | 9 |
Fitting Problem | 9 |
Low Battery | 8 |
No Device Output | 8 |
Defective Device | 7 |
Header | 7 |
Application Program Version Or Upgrade Problem | 6 |
Cap | 6 |
Material Integrity Problem | 6 |
Energy Output Problem | 6 |
Lead | 6 |
Device Alarm System | 6 |
Device Damaged By Another Device | 6 |
Device Packaging Compromised | 6 |
Failure To Convert Rhythm | 5 |
Material Erosion | 5 |
Noise, Audible | 5 |
Total Device Problems | 15307 |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Medtronic Inc., Cardiac Rhythm And Heart Failure | II | Jan-19-2018 |
2 | Medtronic Inc., Cardiac Rhythm And Heart Failure | II | Jul-05-2016 |
3 | Medtronic Inc., Cardiac Rhythm And Heart Failure | II | May-04-2016 |
4 | Medtronic Inc., Cardiac Rhythm And Heart Failure (CRHF) | I | Feb-14-2019 |
5 | St Jude Medical Cardiac Rhythm Management Division | II | Sep-28-2015 |
6 | St Jude Medical Cardiac Rhythm Management Division | II | Jan-09-2015 |