4398
Attain Performa Straight
ALL
Device Survival Probability
4398_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.5 | 99.2 | 99.2 | 98.9 | 98.9 | 98.9 | |||
| # | 1499 | 1143 | 836 | 542 | 281 | 129 | 54 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 2031 |
|---|---|
| Cumulative Months of Follow-Up | 64512 |
| Number of Leads Active in Study | 1179 |
13
Qualifying Complications
| Extra Cardiac Stimulation | 1 |
|---|---|
| Failure to Capture | 4 |
| Impedance Out of Range | 1 |
| Lead Dislodgement | 7 |
| Other | 0 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 8 |
|---|---|
| Conductor Fracture | 1 |
| Extra Cardiac Stimulation | 105 |
| Failure to Capture | 76 |
| Impedance Out of Range | 12 |
| Lead Dislodgement | 41 |
Distribution Data
| US Market Release | 2014-12-10 |
|---|---|
| CE Approval Date | 2013-01-01 |
| Registered USA Implants | 39620 |
| Estimated Active USA Implants | 31643 |
| US Market Release | 2014-12-10 |
|---|---|
| CE Approval Date | 2013-01-01 |
| Estimated WW Distribution | 78199 |
USA Returned Product Analysis
| Conductor Fracture | 4 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 7 |
WW Returned Product Analysis
| Conductor Fracture | 4 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 10 |
Product Characteristics
| Lead Type | Left-Heart |
|---|---|
| Type and/or Fixation | Tines |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Left Ventricular Cardiac Vein |
| Pace/Sense Polarity | Quadripolar |
| Serial Number Prefix | QUB |
|---|---|
| Lead Body Diameter | 5.3 FR |
| Insulation | Polyurethane (outer) Silicone (inner) |
| Pace/Sense Connector Style | IS-4 |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of December 1, 2023