6996
Sub-Q Lead
ALL
Device Survival Probability
| at 0 mo |
|---|
System Longevity Study Results
| Number of Leads Enrolled in Study | 41 |
|---|---|
| Cumulative Months of Follow-Up | 1087 |
| Number of Leads Active in Study | 20 |
2
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Impedance Out of Range | 1 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Failure to Capture | 1 |
|---|---|
| Impedance Out of Range | 2 |
| Lead Dislodgement | 1 |
Distribution Data
| US Market Release | 2001-06-11 |
|---|---|
| CE Approval Date | 1997-12-19 |
| Registered USA Implants | 3753 |
| Estimated Active USA Implants | 2221 |
| US Market Release | 2001-06-11 |
|---|---|
| CE Approval Date | 1997-12-19 |
| Estimated WW Distribution | 7391 |
USA Returned Product Analysis
| Conductor Fracture | 19 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 24 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
Product Characteristics
| Lead Type | Defibrillation |
|---|---|
| Type and/or Fixation | Suture on Anchor Sleeve |
| Lead Function | Defibrillation Electrode |
| Lead Placement | Subcutaneous |
| Lead Tip Location | Subcutaneous |
| Pace/Sense Polarity | n/a |
| Serial Number Prefix | TCR |
|---|---|
| Lead Body Diameter | 7.5 FR |
| Insulation | Silicone |
| Pace/Sense Connector Style | n/a |
| High Voltage Connector | DF-1 |
| Steroid | None |
Data as of March 12, 2013