6949
Sprint Fidelis
ALL
Device Survival Probability
6949_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 | 13 yr | at 162.0 mo | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
98.5 | 96.5 | 93.4 | 91.0 | 88.2 | 84.4 | 81.5 | 79.0 | 78.2 | 76.9 | 71.2 | 68.7 | 66.4 | 65.4 | |||||||
| # | 717 | 624 | 530 | 456 | 390 | 342 | 281 | 235 | 187 | 152 | 125 | 96 | 74 | 56 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 981 |
|---|---|
| Cumulative Months of Follow-Up | 56096 |
| Number of Leads Active in Study | 68 |
130
Qualifying Complications
| Conductor Fracture | 74 |
|---|---|
| Failure to Capture | 5 |
| Failure to Sense | 6 |
| Impedance Out of Range | 19 |
| Insulation (not further defined) | 2 |
| Lead Dislodgement | 1 |
| Oversensing | 21 |
| Other | 2 |
US Acute Lead Observations
| Cardiac Perforation | 10 |
|---|---|
| Conductor Fracture | 51 |
| Failure to Capture | 32 |
| Failure to Sense | 19 |
| Impedance Out of Range | 19 |
| Insulation Breach | 5 |
| Lead Dislodgement | 22 |
| Oversensing | 36 |
| Unspecified Clinical Failure | 24 |
Distribution Data
| US Market Release | 2004-09-02 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 186231 |
| Estimated Active USA Implants | 25641 |
| US Market Release | 2004-09-02 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 236463 |
USA Returned Product Analysis
| Conductor Fracture | 8073 |
|---|---|
| Insulation Breach | 37 |
| Crimp/Weld/Bond | 3 |
| Other | 107 |
WW Returned Product Analysis
| Conductor Fracture | 9316 |
|---|---|
| Insulation Breach | 43 |
| Crimp/Weld/Bond | 3 |
| Other | 132 |
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 | LFJ |
|---|---|
| Lead Body Diameter | 6.6 FR |
| Insulation | Silicone with Polyurethane Overlay |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | DF-1 |
| Steroid | Yes |
Data as of October 11, 2021