5072
SureFix
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | 10 yr | 11 yr | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.8 | 99.8 | 99.4 | 99.4 | 99.4 | 99.4 | 99.4 | 99.4 | 98.5 | 98.5 | |
| # | 376 | 316 | 268 | 222 | 187 | 164 | 134 | 112 | 93 | 75 | 54 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 508 |
|---|---|
| Cumulative Months of Follow-Up | 27962 |
| Number of Leads Active in Study | 55 |
3
Qualifying Complications
| Cardiac Perforation | 1 |
|---|---|
| Failure to Capture | 1 |
| Failure to Sense | 1 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Failure to Capture | 2 |
|---|---|
| Lead Dislodgement | 2 |
Distribution Data
| US Market Release | 1998-06-05 |
|---|---|
| CE Approval Date | 1997-09-25 |
| Registered USA Implants | 10031 |
| Estimated Active USA Implants | 4186 |
| US Market Release | 1998-06-05 |
|---|---|
| CE Approval Date | 1997-09-25 |
| Estimated WW Distribution | 15637 |
USA Returned Product Analysis
| Conductor Fracture | 3 |
|---|---|
| Insulation Breach | 6 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 4 |
|---|---|
| Insulation Breach | 11 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
Product Characteristics
| Lead Type | Pacing |
|---|---|
| Type and/or Fixation | Fixed Screw |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Atrium or Right Ventricle |
| Pace/Sense Polarity | Bipolar |
| Serial Number Prefix | LEM |
|---|---|
| Lead Body Diameter | 7.2 FR |
| Insulation | Silicone |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | n/a |
| Steroid | Steroid |
Data as of March 12, 2013