4194
Attain OTW
ALL
Device Survival Probability
4194_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 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
98.6 | 97.4 | 96.7 | 96.1 | 95.6 | 94.4 | 94.2 | 93.4 | 93.4 | 93.0 | 92.4 | ||||||||||
| # | 1377 | 1155 | 969 | 803 | 667 | 496 | 340 | 245 | 153 | 99 | 61 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1640 |
|---|---|
| Cumulative Months of Follow-Up | 86600 |
| Number of Leads Active in Study | 333 |
65
Qualifying Complications
| Conductor Fracture | 2 |
|---|---|
| Extra Cardiac Stimulation | 11 |
| Failure to Capture | 19 |
| Impedance Out of Range | 0 |
| Insulation (ESC) | 1 |
| Insulation (not further defined) | 2 |
| Lead Dislodgement | 30 |
| Other | 0 |
Customer Communications For This Model
US Acute Lead Observations
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 2 |
| Extra Cardiac Stimulation | 49 |
| Failure to Capture | 42 |
| Impedance Out of Range | 9 |
| Lead Dislodgement | 151 |
| Oversensing | 2 |
| Unspecified Clinical Failure | 4 |
Distribution Data
| US Market Release | 2004-08-24 |
|---|---|
| CE Approval Date | 2003-07-14 |
| Registered USA Implants | 114795 |
| Estimated Active USA Implants | 50180 |
| US Market Release | 2004-08-24 |
|---|---|
| CE Approval Date | 2003-07-14 |
| Estimated WW Distribution | 240396 |
USA Returned Product Analysis
| Conductor Fracture | 37 |
|---|---|
| Insulation Breach | 140 |
| Crimp/Weld/Bond | 0 |
| Other | 2 |
WW Returned Product Analysis
| Conductor Fracture | 43 |
|---|---|
| Insulation Breach | 145 |
| Crimp/Weld/Bond | 0 |
| Other | 3 |
Product Characteristics
| Lead Type | Left-Heart |
|---|---|
| Type and/or Fixation | Double Curve |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Left Ventricular Cardiac Vein |
| Pace/Sense Polarity | Bipolar |
| Serial Number Prefix | LFG |
|---|---|
| Lead Body Diameter | 6.0 FR |
| Insulation | Polyurethane (55D) outer; silicone inner |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of November 8, 2019