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Lumax Family of ICDs and CRT‑Ds - BIOTRONIK USA - News

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22 <strong>Lumax</strong> <strong>Family</strong> Technical Manual<br />

Category<br />

Table 5: Summary <strong>of</strong> Observations—Tupos LV⁄ATx<br />

# <strong>of</strong><br />

Pts<br />

% <strong>of</strong><br />

Pts<br />

Procedure Related<br />

# <strong>of</strong><br />

Complications<br />

Complications<br />

per pt‐year<br />

Hematoma 10 7.52% 10 0.10<br />

Cardiac arrest 2 1.50% 2 0.02<br />

Unable to implant<br />

system<br />

1 0.75% 1 0.01<br />

Total 13 9.77% 13 0.13<br />

Atrial Lead Related<br />

Dislodgement 1 0.75% 1 0.01<br />

High threshold 1 0.75% 1 0.01<br />

Total 2 1.50% 2 0.02<br />

ICD Lead Related<br />

High threshold⁄ No<br />

capture<br />

1 0.75% 1 0.01<br />

Total 1 0.75% 1 0.01<br />

LV Lead Related<br />

High threshold⁄<br />

Intermittent<br />

biventricular<br />

capture⁄<br />

No capture<br />

24 18.05% 24 0.24<br />

Diaphragmatic⁄<br />

Intercostal<br />

8 6.02% 8 0.08<br />

stimulation<br />

Total 30 22.56% 32 0.31<br />

Device Related<br />

Infection 1 0.75% 1 0.01<br />

Inductions <strong>and</strong><br />

conversions<br />

6 4.51% 6 0.06<br />

Inappropriate<br />

sensing<br />

20 15.04% 20 0.20

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