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 | 13 yr | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
98.0 | 97.3 | 96.6 | 95.9 | 95.7 | 95.2 | 94.8 | 94.2 | 93.9 | 93.6 | 93.6 | 93.1 | 93.1 | ||||||||
| # | 1887 | 1499 | 1192 | 964 | 792 | 636 | 495 | 410 | 339 | 262 | 194 | 134 | 51 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2323 |
|---|---|
| Cumulative Months of Follow-Up | 119377 |
| Number of Leads Active in Study | 219 |
87
Qualifying Complications
| Conductor Fracture | 3 |
|---|---|
| Extra Cardiac Stimulation | 17 |
| Failure to Capture | 37 |
| 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 | 67 |
| Failure to Sense | 1 |
| Impedance Out of Range | 12 |
| Insulation Breach | 1 |
| Lead Dislodgement | 227 |
| Oversensing | 1 |
| Unspecified Clinical Failure | 2 |
Distribution Data
| US Market Release | 2009-05-15 |
|---|---|
| CE Approval Date | 2007-07-24 |
| Registered USA Implants | 68956 |
| Estimated Active USA Implants | 27779 |
| US Market Release | 2009-05-15 |
|---|---|
| CE Approval Date | 2007-07-24 |
| Estimated WW Distribution | 222741 |
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 April 30, 2024