6937A Transvene SVC-CS
Defibrillation
ALL
Device Survival Probability
6933_6937_6937A_6963_SURV
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1 yr |
2 yr |
3 yr |
4 yr |
5 yr |
6 yr |
7 yr |
8 yr |
9 yr |
at 114.0 mo |
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% |
 |
99.2 |
99.2 |
99.2 |
98.3 |
95.6 |
93.6 |
92.5 |
91.3 |
88.8 |
88.8 |
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# |
|
119 |
117 |
114 |
109 |
98 |
87 |
80 |
73 |
61 |
55 |
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Product Surveillance Registry Results
Number of Leads Enrolled in Study |
127 |
Cumulative Months of Follow-Up |
14613 |
Number of Leads Active in Study |
7 |
16
Qualifying Complications
Conductor Fracture |
6 |
Impedance Out of Range |
2 |
Insulation (not further defined) |
2 |
Lead Dislodgement |
1 |
Other |
1 |
Unspecified Clinical Failure |
4 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
Cardiac Perforation |
1 |
Conductor Fracture |
3 |
Impedance Out of Range |
2 |
Lead Dislodgement |
1 |
Oversensing |
2 |
Unspecified Clinical Failure |
2 |
Product Characteristics
Lead Type |
Defibrillation |
Type and/or Fixation |
Passive |
Lead Function |
Defibrillation Electrode |
Lead Placement |
Transvenous |
Lead Tip Location |
SVC/CS |
Pace/Sense Polarity |
One Coil |
More
Serial Number Prefix |
TDB |
Lead Body Diameter |
7.5 FR |
Insulation |
Silicone with Polyurethane Overlay |
Pace/Sense Connector Style |
n/a |
High Voltage Connector |
DF-1 |
Steroid |
None |
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