User's Manual

Premature battery depletion
Sensing or pacing issues
Error codes
Loss of telemetry
Refer to Boston Scientic’s CRM Product Performance Report on www.bostonscientic.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 c ontext for understanding the overall reliability of these types of products.
Sometimes device malfunctions result in the issuance of product advisories. Boston Scientic determines the
need to issue product advisories based on the estimated malfunction rate and the clinical implication of the
malfunction. When Boston Scientic c ommunicates 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 debrillation—the patient should contact their physician to have their pulse generator system
evaluated if they receive external debrillation
Signs and symptoms of infection
Symptoms that should be reported (e.g., sustained high-rate pacing requiring reprogramming)
Protected environments—the patient should seek medical guidance before entering areas protected by a
warning notice that prevents entry by patients who have a pulse generator
Avoiding potential sources of EMI in home, work, and medical environments
Reliability of their pulse generator ("Product Reliability" on page 46)
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