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 | 11 yr | 12 yr | 13 yr | 14 yr | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
96.0 | 95.1 | 94.4 | 94.1 | 93.4 | 92.6 | 92.2 | 91.7 | 91.2 | 90.5 | 90.5 | 88.4 | 88.4 | 88.4 | |||||||
| # | 569 | 444 | 376 | 304 | 252 | 228 | 193 | 171 | 139 | 118 | 97 | 78 | 62 | 50 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 805 |
|---|---|
| Cumulative Months of Follow-Up | 42295 |
| Number of Leads Active in Study | 32 |
51
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Extra Cardiac Stimulation | 10 |
| Failure to Capture | 20 |
| Impedance Out of Range | 2 |
| Lead Dislodgement | 15 |
| Other | 0 |
| Unspecified Clinical Failure | 3 |
Customer Communications For This Model
- There are no communications 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 | 100664 |
| Estimated Active USA Implants | 12387 |
| US Market Release | 2002-05-03 |
|---|---|
| CE Approval Date | 2000-12-22 |
| Estimated WW Distribution | 193226 |
USA Returned Product Analysis
| Conductor Fracture | 91 |
|---|---|
| Insulation Breach | 31 |
| Crimp/Weld/Bond | 0 |
| Other | 15 |
WW Returned Product Analysis
| Conductor Fracture | 98 |
|---|---|
| Insulation Breach | 31 |
| Crimp/Weld/Bond | 0 |
| Other | 33 |
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 May 10, 2023