5086MRI CapsureFix Novus MRI
Pacing
VENTRICULAR PLACEMENT
Device Survival Probability
5086MRI_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 |
13 yr |
|
|
|
|
|
|
|
|
| % |
 |
99.7 |
99.7 |
99.6 |
99.6 |
99.6 |
99.3 |
98.3 |
98.0 |
98.0 |
98.0 |
98.0 |
97.6 |
97.6 |
|
|
|
|
|
|
|
|
| # |
|
2525 |
2182 |
1850 |
1425 |
734 |
422 |
374 |
331 |
300 |
277 |
212 |
131 |
62 |
|
|
|
|
|
|
|
|
Product Surveillance Registry Results
| Number of Leads Enrolled in Study |
3072 |
| Cumulative Months of Follow-Up |
146399 |
| Number of Leads Active in Study |
1231 |
21
Qualifying Complications
| Conductor Fracture |
3 |
| Failure to Capture |
8 |
| Failure to Sense |
2 |
| Impedance Out of Range |
2 |
| Lead Dislodgement |
3 |
| Oversensing |
2 |
| Other |
1 |
ATRIAL PLACEMENT
Device Survival Probability
5086MRI_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 |
|
|
|
|
|
|
|
|
| % |
 |
99.8 |
99.6 |
99.6 |
99.4 |
99.3 |
98.9 |
98.4 |
98.4 |
98.4 |
98.1 |
98.1 |
98.1 |
98.1 |
|
|
|
|
|
|
|
|
| # |
|
2528 |
2202 |
1878 |
1460 |
766 |
453 |
398 |
354 |
320 |
296 |
230 |
141 |
64 |
|
|
|
|
|
|
|
|
Product Surveillance Registry Results
| Number of Leads Enrolled in Study |
3142 |
| Cumulative Months of Follow-Up |
149577 |
| Number of Leads Active in Study |
1250 |
21
Qualifying Complications
| Conductor Fracture |
3 |
| Failure to Capture |
3 |
| Lead Dislodgement |
12 |
| Oversensing |
2 |
| Other |
1 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation |
213 |
| Conductor Fracture |
4 |
| Extra Cardiac Stimulation |
18 |
| Failure to Capture |
144 |
| Failure to Sense |
29 |
| Impedance Out of Range |
9 |
| Insulation Breach |
2 |
| Lead Dislodgement |
312 |
| Oversensing |
32 |
Product Characteristics
| Lead Type |
Pacing |
| Type and/or Fixation |
Active Screw In |
| Lead Function |
Pacing/Sensing |
| Lead Placement |
Transvenous |
| Lead Tip Location |
Atrium or Right Ventricle |
| Pace/Sense Polarity |
Bipolar |
More
| Serial Number Prefix |
LFP |
| Lead Body Diameter |
6.9 FR |
| Insulation |
Silicone |
| Pace/Sense Connector Style |
IS-1 BI |
| High Voltage Connector |
n/a |
| Steroid |
Yes |
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Data as of December 1, 2025