5054
CapSure Z Novus
VENTRICULAR PLACEMENT
Device Survival Probability
5054_VEN_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 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.3 | 99.1 | 98.8 | 98.4 | 98.4 | 97.0 | 97.0 | 96.4 | 96.4 | 96.4 | 96.4 | 96.4 | |||||||||
| # | 474 | 391 | 304 | 264 | 230 | 191 | 167 | 143 | 112 | 92 | 71 | 52 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 989 |
|---|---|
| Cumulative Months of Follow-Up | 35298 |
| Number of Leads Active in Study | 18 |
13
Qualifying Complications
| Failure to Capture | 7 |
|---|---|
| Failure to Sense | 2 |
| Impedance Out of Range | 1 |
| Lead Dislodgement | 1 |
| Other | 2 |
ATRIAL PLACEMENT
Device Survival Probability
5054_ATR_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 | 15 yr | 16 yr | at 198.0 mo | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % | |
99.5 | 99.5 | 99.5 | 99.5 | 99.5 | 99.5 | 99.5 | 99.5 | 99.5 | 99.5 | 99.5 | 99.5 | 99.5 | 99.5 | 99.5 | 99.5 | 99.5 | ||||
| # | 411 | 391 | 358 | 322 | 289 | 252 | 219 | 186 | 153 | 129 | 108 | 93 | 75 | 65 | 59 | 52 | 51 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 426 |
|---|---|
| Cumulative Months of Follow-Up | 41851 |
| Number of Leads Active in Study | 33 |
3
Qualifying Complications
| Failure to Capture | 2 |
|---|---|
| Impedance Out of Range | 0 |
| Lead Dislodgement | 1 |
| Other | 0 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 2 |
| Failure to Capture | 23 |
| Impedance Out of Range | 4 |
| Insulation Breach | 1 |
| Lead Dislodgement | 30 |
| Unspecified Clinical Failure | 9 |
Distribution Data
| US Market Release | 1998-06-03 |
|---|---|
| CE Approval Date | 1997-06-05 |
| Registered USA Implants | 100057 |
| Estimated Active USA Implants | 18608 |
| US Market Release | 1998-06-03 |
|---|---|
| CE Approval Date | 1997-06-05 |
| Estimated WW Distribution | 500740 |
USA Returned Product Analysis
| Conductor Fracture | 16 |
|---|---|
| Insulation Breach | 45 |
| Crimp/Weld/Bond | 1 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 22 |
|---|---|
| Insulation Breach | 51 |
| Crimp/Weld/Bond | 1 |
| Other | 5 |
Product Characteristics
| Lead Type | Pacing |
|---|---|
| Type and/or Fixation | Tines |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Right Ventricle |
| Pace/Sense Polarity | Bipolar |
| Serial Number Prefix | LEH |
|---|---|
| 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