5554
CapSure Z Novus
ALL
Device Survival Probability
5554_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 98.2 | 97.2 | 96.0 | 96.0 | 96.0 | 96.0 | |||
| # | 141 | 107 | 84 | 77 | 63 | 55 | 55 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 367 |
|---|---|
| Cumulative Months of Follow-Up | 9386 |
| Number of Leads Active in Study | 7 |
5
Qualifying Complications
| Failure to Capture | 2 |
|---|---|
| Impedance Out of Range | 1 |
| Lead Dislodgement | 1 |
| Oversensing | 1 |
| Other | 0 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Conductor Fracture | 1 |
|---|---|
| Failure to Capture | 31 |
| Failure to Sense | 2 |
| Impedance Out of Range | 1 |
| Lead Dislodgement | 39 |
| Unspecified Clinical Failure | 3 |
Distribution Data
| US Market Release | 1998-06-03 |
|---|---|
| CE Approval Date | 1997-06-05 |
| Registered USA Implants | 64866 |
| Estimated Active USA Implants | 14456 |
| US Market Release | 1998-06-03 |
|---|---|
| CE Approval Date | 1997-06-05 |
| Estimated WW Distribution | 252982 |
USA Returned Product Analysis
| Conductor Fracture | 24 |
|---|---|
| Insulation Breach | 42 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 59 |
|---|---|
| Insulation Breach | 53 |
| Crimp/Weld/Bond | 0 |
| Other | 2 |
Product Characteristics
| Lead Type | Pacing |
|---|---|
| Type and/or Fixation | Tines |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Atrium - J |
| Pace/Sense Polarity | Bipolar |
| Serial Number Prefix | LEJ |
|---|---|
| Lead Body Diameter | 6.0 FR |
| Insulation | Silicone |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of May 10, 2023