4558M
Screw-In
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | |||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.3 | 99.3 | 99.3 | 99.3 | 99.3 | 97.6 | 96.5 | 96.5 | 91.8 | |
| # | 353 | 296 | 249 | 191 | 139 | 96 | 83 | 66 | 50 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 539 |
|---|---|
| Cumulative Months of Follow-Up | 23289 |
| Number of Leads Active in Study | 6 |
12
Qualifying Complications
| Electrical Abandonment | 1 |
|---|---|
| Failure to Capture | 3 |
| Failure to Sense | 2 |
| Impedance Out of Range | 2 |
| Insulation (not further defined) | 2 |
| Oversensing | 2 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 2 |
|---|---|
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 2 |
| Failure to Sense | 1 |
| Impedance Out of Range | 1 |
| Lead Dislodgement | 2 |
| Unspecified Clinical Failure | 1 |
Distribution Data
| US Market Release | 1994-11-14 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 19440 |
| Estimated Active USA Implants | 3842 |
| US Market Release | 1994-11-14 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 20937 |
USA Returned Product Analysis
| Conductor Fracture | 1 |
|---|---|
| Insulation Breach | 18 |
| Crimp/Weld/Bond | 0 |
| Other | 20 |
WW Returned Product Analysis
| Conductor Fracture | 1 |
|---|---|
| Insulation Breach | 20 |
| Crimp/Weld/Bond | 0 |
| Other | 65 |
Product Characteristics
| Lead Type | Pacing |
|---|---|
| Type and/or Fixation | Active Screw In |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Atrium - J |
| Pace/Sense Polarity | Bipolar |
| Serial Number Prefix | LDC |
|---|---|
| Lead Body Diameter | 7.5 FR |
| Insulation | Polyurethane |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | n/a |
| Steroid | None |
Data as of March 12, 2013