6947M
Sprint Quattro Secure
ALL
Device Survival Probability
6947M_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 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.5 | 99.4 | 99.4 | 99.0 | 98.9 | 98.2 | 97.9 | 97.4 | 97.1 | 97.1 | ||||||||||
| # | 1862 | 1554 | 1365 | 1163 | 1003 | 848 | 713 | 595 | 476 | 315 | 81 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2410 |
|---|---|
| Cumulative Months of Follow-Up | 132529 |
| Number of Leads Active in Study | 671 |
28
Qualifying Complications
| Conductor Fracture | 15 |
|---|---|
| Failure to Capture | 4 |
| Failure to Sense | 4 |
| Impedance Out of Range | 1 |
| Lead Dislodgement | 1 |
| Oversensing | 2 |
| Other | 1 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 40 |
|---|---|
| Conductor Fracture | 15 |
| Extra Cardiac Stimulation | 12 |
| Failure to Capture | 124 |
| Failure to Sense | 47 |
| Impedance Out of Range | 36 |
| Insulation Breach | 1 |
| Lead Dislodgement | 241 |
| Oversensing | 86 |
Distribution Data
| US Market Release | 2012-02-13 |
|---|---|
| CE Approval Date | 2010-03-12 |
| Registered USA Implants | 137519 |
| Estimated Active USA Implants | 94732 |
| US Market Release | 2012-02-13 |
|---|---|
| CE Approval Date | 2010-03-12 |
| Estimated WW Distribution | 283714 |
USA Returned Product Analysis
| Conductor Fracture | 257 |
|---|---|
| Insulation Breach | 15 |
| Crimp/Weld/Bond | 1 |
| Other | 37 |
WW Returned Product Analysis
| Conductor Fracture | 392 |
|---|---|
| Insulation Breach | 21 |
| Crimp/Weld/Bond | 1 |
| Other | 43 |
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/Two Coils |
| Serial Number Prefix | TDK |
|---|---|
| Lead Body Diameter | 8.6 FR |
| Insulation | Silicone with Polyurethane Overlay |
| Pace/Sense Connector Style | DF4-LLHH |
| High Voltage Connector | DF4-LLHH |
| Steroid | Yes |
Data as of April 30, 2024