4598
Attain Performa S
ALL
Device Survival Probability
4598_SURV
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| 1 yr | 2 yr | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
98.9 | 98.9 | ||||||||
| # | 344 | 111 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 723 |
|---|---|
| Cumulative Months of Follow-Up | 9097 |
| Number of Leads Active in Study | 609 |
6
Qualifying Complications
| Failure to Sense | 1 |
|---|---|
| Lead Dislodgement | 5 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 4 |
|---|---|
| Conductor Fracture | 1 |
| Extra Cardiac Stimulation | 45 |
| Failure to Capture | 23 |
| Impedance Out of Range | 5 |
| Lead Dislodgement | 27 |
| Oversensing | 1 |
Distribution Data
| US Market Release | 2014-12-10 |
|---|---|
| CE Approval Date | 2013-01-01 |
| Registered USA Implants | 25448 |
| Estimated Active USA Implants | 24395 |
| US Market Release | 2014-12-10 |
|---|---|
| CE Approval Date | 2013-01-01 |
| Estimated WW Distribution | 54491 |
USA Returned Product Analysis
| Conductor Fracture | 3 |
|---|---|
| Insulation Breach | 1 |
| Crimp/Weld/Bond | 0 |
| Other | 1 |
WW Returned Product Analysis
| Conductor Fracture | 7 |
|---|---|
| Insulation Breach | 1 |
| Crimp/Weld/Bond | 0 |
| Other | 3 |
Product Characteristics
| Lead Type | Left-Heart |
|---|---|
| Type and/or Fixation | Canted |
| 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 January 31, 2018