4196
Attain Ability
ALL
Device Survival Probability
4196_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | 10 yr | 11 yr | 12 yr | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
98.0 | 97.3 | 96.6 | 95.9 | 95.5 | 94.8 | 94.5 | 93.8 | 93.0 | 92.6 | 92.6 | 92.1 | |||||||||
| # | 1884 | 1495 | 1188 | 960 | 786 | 619 | 487 | 395 | 314 | 232 | 165 | 67 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2318 |
|---|---|
| Cumulative Months of Follow-Up | 116139 |
| Number of Leads Active in Study | 255 |
92
Qualifying Complications
| Conductor Fracture | 3 |
|---|---|
| Extra Cardiac Stimulation | 17 |
| Failure to Capture | 42 |
| Impedance Out of Range | 2 |
| Insulation (not further defined) | 1 |
| Lead Dislodgement | 23 |
| Other | 4 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 3 |
|---|---|
| Conductor Fracture | 2 |
| Extra Cardiac Stimulation | 98 |
| Failure to Capture | 66 |
| Failure to Sense | 1 |
| Impedance Out of Range | 12 |
| Insulation Breach | 1 |
| Lead Dislodgement | 228 |
| Oversensing | 1 |
| Unspecified Clinical Failure | 2 |
Distribution Data
| US Market Release | 2009-05-15 |
|---|---|
| CE Approval Date | 2007-07-24 |
| Registered USA Implants | 68727 |
| Estimated Active USA Implants | 27947 |
| US Market Release | 2009-05-15 |
|---|---|
| CE Approval Date | 2007-07-24 |
| Estimated WW Distribution | 218953 |
USA Returned Product Analysis
| Conductor Fracture | 26 |
|---|---|
| Insulation Breach | 2 |
| Crimp/Weld/Bond | 0 |
| Other | 9 |
WW Returned Product Analysis
| Conductor Fracture | 38 |
|---|---|
| Insulation Breach | 3 |
| Crimp/Weld/Bond | 0 |
| Other | 12 |
Product Characteristics
| Lead Type | Left-Heart |
|---|---|
| Type and/or Fixation | Double Curve |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Left Ventricular Cardiac Vein |
| Pace/Sense Polarity | Bipolar |
| Serial Number Prefix | PVI |
|---|---|
| Lead Body Diameter | 4.0 FR |
| Insulation | Polyurethane (outer); SI-polyimide (inner) |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of May 10, 2023