6996
Sub-Q Lead
ALL
Device Survival Probability
6996_SURV
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| at 0.0 mo | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | |||||||||
| # | 0 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 52 |
|---|---|
| Cumulative Months of Follow-Up | 2165 |
| Number of Leads Active in Study | 9 |
3
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Impedance Out of Range | 2 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 1 |
|---|---|
| Failure to Capture | 1 |
| Impedance Out of Range | 10 |
| Insulation Breach | 1 |
| Lead Dislodgement | 1 |
| Oversensing | 1 |
Distribution Data
| US Market Release | 2001-06-11 |
|---|---|
| CE Approval Date | 1997-12-19 |
| Registered USA Implants | 4970 |
| Estimated Active USA Implants | 2728 |
| US Market Release | 2001-06-11 |
|---|---|
| CE Approval Date | 1997-12-19 |
| Estimated WW Distribution | 10705 |
USA Returned Product Analysis
| Conductor Fracture | 30 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 42 |
|---|---|
| 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 | Defibrillation |
| Pace/Sense Polarity | One Coil |
| 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 October 12, 2018