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Enpath Lead Adapters: The internal component (Connector Block) of the Lead Adapter used to secure a lead to the adapter has exhibited varying degress of radial cracks that could cause a temporary intermittent electrical signal disruption if lateral tension is applied to device.
Decrease in sensitivity ; This could result in a false negative result for patients with weak to moderate lupus anticoagulants.
The internal component (Connector Block) of the Lead Adapter used to secure a lead to the adapter has exhibited varying degress of radial cracks that could cause a temporary intermittent electrical signal disruption if lateral tension is applied to device.