4598
Attain Performa S
ALL
Device Survival Probability
4598_SURV
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| 1 yr | 2 yr | 3 yr | at 42.0 mo | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.2 | 99.0 | 99.0 | 99.0 | ||||||
| # | 684 | 404 | 184 | 99 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1174 |
|---|---|
| Cumulative Months of Follow-Up | 21840 |
| Number of Leads Active in Study | 902 |
8
Qualifying Complications
| Extra Cardiac Stimulation | 2 |
|---|---|
| Failure to Capture | 0 |
| Failure to Sense | 1 |
| Impedance Out of Range | 0 |
| Lead Dislodgement | 5 |
| Other | 0 |
Customer Communications For This Model
US Acute Lead Observations
| Cardiac Perforation | 8 |
|---|---|
| Conductor Fracture | 1 |
| Extra Cardiac Stimulation | 69 |
| Failure to Capture | 37 |
| Impedance Out of Range | 13 |
| Lead Dislodgement | 42 |
| Oversensing | 1 |
Distribution Data
| US Market Release | 2014-12-10 |
|---|---|
| CE Approval Date | 2013-01-01 |
| Registered USA Implants | 41957 |
| Estimated Active USA Implants | 39704 |
| US Market Release | 2014-12-10 |
|---|---|
| CE Approval Date | 2013-01-01 |
| Estimated WW Distribution | 85535 |
USA Returned Product Analysis
| Conductor Fracture | 4 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 4 |
WW Returned Product Analysis
| Conductor Fracture | 9 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 8 |
Product Characteristics
| Lead Type | Left-Heart |
|---|---|
| Type and/or Fixation | S-shape |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Left Ventricular Cardiac Vein |
| Pace/Sense Polarity | Quad Pole |
| Serial Number Prefix | QUC |
|---|---|
| Lead Body Diameter | 5.3 FR |
| Insulation | Polyurethane (outer) SI-polyimide (SI-PI)(inner) |
| Pace/Sense Connector Style | IS4-LLLL |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of November 8, 2019