PRODUCT RELIABILITY
It is Boston Scienti
fi
c’s intent to provide implantable devices of high quality and reliability. However, these
devices may exhibit malfunctions that may result in lost or compromised ability to deliver therapy. These
malfunctions may include the following:
•
Premature battery depletion
•
Sensing or pacing issues
•
Inability to shock
•
Error codes
•
Loss of telemetry
Refer to Boston Scienti
fi
c’s CRM Product Performance Report on www.bostonscienti
fi
c.com for more
information about device performance, including the types and rates of malfunctions that these devices have
experienced historically. While historical data may not be predictive of future device performance, such data
can provide important context for understanding the overall reliability of these types of products.
Sometimes device malfunctions result in the issuance of product advisories. Boston Scienti
fi
c determines the
need to issue product advisories based on the estimated malfunction rate and the clinical implication of the
malfunction. When Boston Scienti
fi
c communicates product advisory information, the decision whether to
replace a device should take into account the risks of the malfunction, the risks of the replacement procedure,
and the performance to date of the replacement device.
PATIENT COUNSELING INFORMATION
The following topics should be discussed with the patient prior to discharge.
•
External de
fi
brillation—the patient should contact their physician to have their pulse generator system
evaluated if they receive external de
fi
brillation
•
Beeping tones—the patient should contact their physician immediately if they hear tones coming from
their pulse generator
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