6996
Sub-Q Lead
ALL
Device Survival Probability
6996_SURV
Loading...
| at 0.0 mo | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | |||||||||
| # | 0 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 53 |
|---|---|
| Cumulative Months of Follow-Up | 2262 |
| Number of Leads Active in Study | 7 |
3
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Failure to Capture | 0 |
| Impedance Out of Range | 2 |
| Other | 0 |
Customer Communications For This Model
US Acute Lead Observations
| Cardiac Perforation | 1 |
|---|---|
| Failure to Capture | 1 |
| Impedance Out of Range | 12 |
| 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 | 5143 |
| Estimated Active USA Implants | 2817 |
| US Market Release | 2001-06-11 |
|---|---|
| CE Approval Date | 1997-12-19 |
| Estimated WW Distribution | 11112 |
USA Returned Product Analysis
| Conductor Fracture | 31 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 44 |
|---|---|
| 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 November 8, 2019