6935M
Sprint Quattro Secure S
ALL
Device Survival Probability
6935M_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 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.6 | 99.5 | 99.2 | 99.0 | 98.7 | 98.3 | 97.9 | 97.5 | 96.9 | 96.3 | 95.9 | ||||||||||
| # | 8054 | 5983 | 4720 | 3853 | 3232 | 2583 | 2047 | 1376 | 742 | 356 | 104 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 10106 |
|---|---|
| Cumulative Months of Follow-Up | 449463 |
| Number of Leads Active in Study | 3588 |
125
Qualifying Complications
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 57 |
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 15 |
| Failure to Sense | 1 |
| Impedance Out of Range | 10 |
| Insulation (not further defined) | 3 |
| Lead Dislodgement | 24 |
| Oversensing | 6 |
| Other | 5 |
| Unspecified Clinical Failure | 1 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 212 |
|---|---|
| Conductor Fracture | 24 |
| Extra Cardiac Stimulation | 35 |
| Failure to Capture | 529 |
| Failure to Sense | 185 |
| Impedance Out of Range | 156 |
| Insulation Breach | 3 |
| Lead Dislodgement | 719 |
| Oversensing | 417 |
Distribution Data
| US Market Release | 2012-08-02 |
|---|---|
| CE Approval Date | 2012-07-12 |
| Registered USA Implants | 435164 |
| Estimated Active USA Implants | 359135 |
| US Market Release | 2012-08-02 |
|---|---|
| CE Approval Date | 2012-07-12 |
| Estimated WW Distribution | 1021604 |
USA Returned Product Analysis
| Conductor Fracture | 890 |
|---|---|
| Insulation Breach | 37 |
| Crimp/Weld/Bond | 2 |
| Other | 105 |
WW Returned Product Analysis
| Conductor Fracture | 1453 |
|---|---|
| Insulation Breach | 59 |
| Crimp/Weld/Bond | 3 |
| Other | 169 |
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 | TDL |
|---|---|
| Lead Body Diameter | 2.8 mm (8.4 Fr) |
| Insulation | Silicone with Polyurethane Overlay |
| Pace/Sense Connector Style | DF4-LLHO |
| High Voltage Connector | DF4-LLHO |
| Steroid | Yes |
Data as of May 24, 2025