6935
Sprint Quattro Secure S
ALL
Device Survival Probability
6935_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 | at 150.0 mo | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | 99.3 | 98.9 | 98.6 | 98.5 | 98.0 | 97.4 | 96.6 | 95.7 | 94.6 | 94.2 | 93.7 | 92.8 | ||||||||
| # | 2376 | 1961 | 1613 | 1318 | 1111 | 953 | 797 | 666 | 544 | 365 | 198 | 104 | 64 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2933 |
|---|---|
| Cumulative Months of Follow-Up | 160037 |
| Number of Leads Active in Study | 752 |
66
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 24 |
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 8 |
| Failure to Sense | 1 |
| Impedance Out of Range | 8 |
| Lead Dislodgement | 8 |
| Oversensing | 9 |
| Other | 5 |
| Unspecified Clinical Failure | 1 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 29 |
|---|---|
| Conductor Fracture | 4 |
| Extra Cardiac Stimulation | 2 |
| Failure to Capture | 32 |
| Failure to Sense | 15 |
| Impedance Out of Range | 28 |
| Insulation Breach | 1 |
| Lead Dislodgement | 68 |
| Oversensing | 65 |
| Unspecified Clinical Failure | 5 |
Distribution Data
| US Market Release | 2008-11-01 |
|---|---|
| CE Approval Date | 2008-03-31 |
| Registered USA Implants | 66206 |
| Estimated Active USA Implants | 38677 |
| US Market Release | 2008-11-01 |
|---|---|
| CE Approval Date | 2008-03-31 |
| Estimated WW Distribution | 203824 |
USA Returned Product Analysis
| Conductor Fracture | 456 |
|---|---|
| Insulation Breach | 13 |
| Crimp/Weld/Bond | 0 |
| Other | 44 |
WW Returned Product Analysis
| Conductor Fracture | 849 |
|---|---|
| Insulation Breach | 32 |
| Crimp/Weld/Bond | 0 |
| Other | 80 |
Product Characteristics
| Lead Type | Defibrillation |
|---|---|
| Type and/or Fixation | Active Screw In |
| Lead Function | Pacing/Sensing and Defibrillation |
| Lead Placement | Transvenous |
| Lead Tip Location | Right Ventricle |
| Pace/Sense Polarity | True Bipolar/One Coil |
| Serial Number Prefix | TAU |
|---|---|
| Lead Body Diameter | 8,2 FR |
| Insulation | Silicone with Polyurethane Overlay |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | DF-1 |
| Steroid | Yes |
Data as of May 10, 2023