Home > Leads > Epi/Myocardial
4951, 4951M Spectraflex |
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|
Product Characteristics |
| US Market Release |
Oct-81 |
|
Serial Number Prefix |
TF or LBJ |
| Registered US Implants |
23,100 |
|
Type and/or Fixation |
Myocardial Stab-in, V or A, Peds |
| Estimated US Active Implants |
2,200 |
|
Polarity |
Unipolar |
| Advisories |
None |
|
Steroid |
No |
| System Longevity Study Results |
|
| US Returned Product Analysis |
| Conductor Fracture |
56 |
| Crimp/Weld/Bond |
0 |
| Insulation Breach |
39 |
| Extrinsic |
7 |
| Other |
29 |
|
| Number of Leads Enrolled in Study |
179 |
| Cumulative Months of Follow-Up |
4,494 |
| Number of Leads Active in Study |
4 |
| |
|
|
| Qualifying Complications |
14 Total |
|
| Conductor Fracture |
1 |
|
| Failure to Capture |
7 |
|
| Failure to Sense |
3 |
|
| Impedance Out of Range |
1 |
|
| Insulation (ESC) |
1 |
|
| Insulation (not further defined) |
1 |
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