4193
Attain OTW
ALL
Device Survival Probability
4193_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 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
96.0 | 95.0 | 94.3 | 94.1 | 93.4 | 92.6 | 92.2 | 91.6 | 91.1 | 90.3 |
| # | 631 | 490 | 414 | 326 | 254 | 206 | 169 | 137 | 90 | 61 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 800 |
|---|---|
| Cumulative Months of Follow-Up | 39105 |
| Number of Leads Active in Study | 78 |
46
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Extra Cardiac Stimulation | 9 |
| Failure to Capture | 17 |
| Impedance Out of Range | 2 |
| Lead Dislodgement | 14 |
| Unspecified Clinical Failure | 3 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Extra Cardiac Stimulation | 18 |
|---|---|
| Failure to Capture | 11 |
| Lead Dislodgement | 45 |
| Oversensing | 1 |
| Unspecified Clinical Failure | 2 |
Distribution Data
| US Market Release | 2002-05-03 |
|---|---|
| CE Approval Date | 2000-12-22 |
| Registered USA Implants | 100812 |
| Estimated Active USA Implants | 23549 |
| US Market Release | 2002-05-03 |
|---|---|
| CE Approval Date | 2000-12-22 |
| Estimated WW Distribution | 190360 |
USA Returned Product Analysis
| Conductor Fracture | 77 |
|---|---|
| Insulation Breach | 27 |
| Crimp/Weld/Bond | 0 |
| Other | 46 |
WW Returned Product Analysis
| Conductor Fracture | 84 |
|---|---|
| Insulation Breach | 27 |
| Crimp/Weld/Bond | 0 |
| Other | 99 |
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 | Unipolar |
| Serial Number Prefix | BAA |
|---|---|
| Lead Body Diameter | 4.0 FR |
| Insulation | Polyurethane (55D) |
| Pace/Sense Connector Style | IS-1 UNI |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of October 12, 2018