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 | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.6 | 99.5 | 99.2 | 98.9 | 98.4 | 97.7 | 97.5 | 97.5 | ||
| # | 5712 | 4615 | 3625 | 2768 | 1746 | 867 | 353 | 52 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 7355 |
|---|---|
| Cumulative Months of Follow-Up | 274486 |
| Number of Leads Active in Study | 4056 |
82
Qualifying Complications
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 27 |
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 16 |
| Failure to Sense | 1 |
| Impedance Out of Range | 7 |
| Insulation (not further defined) | 3 |
| Lead Dislodgement | 17 |
| Oversensing | 5 |
| Other | 2 |
| Unspecified Clinical Failure | 1 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 141 |
|---|---|
| Conductor Fracture | 16 |
| Extra Cardiac Stimulation | 26 |
| Failure to Capture | 291 |
| Failure to Sense | 91 |
| Impedance Out of Range | 85 |
| Insulation Breach | 2 |
| Lead Dislodgement | 506 |
| Oversensing | 259 |
Distribution Data
| US Market Release | 2012-08-02 |
|---|---|
| CE Approval Date | 2012-07-12 |
| Registered USA Implants | 299768 |
| Estimated Active USA Implants | 242583 |
| US Market Release | 2012-08-02 |
|---|---|
| CE Approval Date | 2012-07-12 |
| Estimated WW Distribution | 668151 |
USA Returned Product Analysis
| Conductor Fracture | 521 |
|---|---|
| Insulation Breach | 28 |
| Crimp/Weld/Bond | 1 |
| Other | 76 |
WW Returned Product Analysis
| Conductor Fracture | 891 |
|---|---|
| Insulation Breach | 44 |
| Crimp/Weld/Bond | 1 |
| Other | 117 |
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 December 16, 2021