Inspire 4063 - Surgical Revision and Explant; Lead Repositioning; System or IPG Explant

Inspire System Models 3024, 4063, 4323 English 35
200-079-101 Rev A
3024EN_ch.fm 5/6/14 10:31 pm
4.625 x 6 inches (117 mm x 152 mm)
Inspire Medical Confidential
Surgical Revision and Explant
Lead Repositioning
• If the stimulation or respiratory sensing lead becomes displaced, any repositioning should
be attempted as soon as possible, before scar tissue builds up.
• If the lead must be repositioned (or removed) proceed with caution to avoid damage to
surrounding tissue.
• Extreme forces used during removal can damage leads or result in dismantling of the
leads.
• If removal is unavoidable, return the removed lead, or portion thereof, to Inspire Medical
Systems.
System or IPG Explant
• Extreme forces used during removal can damage the lead or result in dismantling of the
lead.
• A lead that has been cut off should have the remaining lead end sealed.
• If the leads are left in place, the proximal connector ends of the leads should be capped to
minimize tissue irritation and induced currents.
• Lead removal may not be possible due to the risk of damaging surrounding structures. The
decision to remove the leads or leave them in place is made between the physician and
the patient on a case by case basis. The implications of both options should be discussed,
for example:
– Removing the leads will extend the duration of the surgical procedure, require two
additional incisions, and require the dissection of fibrotic tissue that may have formed
around the leads.
– Leaving the leads in place means the patient will still be susceptible to electromagnetic
interference, which may prevent the patient from receiving an MRI. Furthermore,
patients must be made aware that they need to notify medical personnel that they still
have implanted leads even if the IPG has been removed and the lead ends have been
capped.
• Return all explanted components to Inspire Medical Systems for disposal.
Explant Disposition
When replacing an IPG, (due to battery depletion or explanting the IPG at the death of a patient
who is to be cremated) return the IPG to Inspire Medical Systems for analysis and disposal.
See the back cover of this manual for mailing address.