User Manual Part 3

10-8

POST IMPLANT INFORMATION

EXPLANTATION

NOTE: If tachy detection occurs while the magnet is in place, detailed therapy

history will indicate that therapy was not delivered because the device was

in Monitor Only mode.

EXPLANTATION

An Observation/Complication/Out-of-Service Reporting form should be

completed and sent to Boston Scientiﬁc w hen a product is removed from

service. Return all explanted pulse generators and leads with product

performance allegations or warranty considerations to Boston Scientiﬁc.

Examination of explanted devices provides information for continued

improveme nt in device reliability and will permit calculation of an y warranty

replacement cre dit u se .

In the event of patient death (regardless of cause), the explanted pulse

generator and/or lead should be returned to Boston Scientiﬁcalong

with the Observation/Complic ation/Out-of-Service Reporting form and

copies of the autopsy report, if performed. For other observation or

complications reasons, also complete and return to Boston Scientiﬁcthe

Observation/Complication/Out-of-S ervice Reporting form.

NOTE: Disposal of explanted devices is subject to local, state, and federal

regulations . Contact your sales representative o r call the phone number on the

back cover of this manual for a Returned Product Kit.

NOTE: Discoloration of the pulse generator may have occurred due to a

normal process of anodization, and has no effect on the pulse generator

function.

CAUTION: Be sure that the pulse generator is removed before cremation.

Cremation and incineration temperatures might cause the pulse generator to

explode.

CAUTION: Before explanting, cleaning, or shipping the device, complete the

following actions to prevent unwanted shocks, overwriting of important therapy

history data, and audible tones:

• Program the pulse generator Tachy and Brady Modes to Off.

• Program the Magnet Response feature to Off.

• Program the Beep When Explant is Indicated feature to Off.

Consider the following items when explanting and returning the pulse generator:

- DRAFT -