EMBLEM S-ICD Model A209 and EMBLEM MRI S-ICD Model A219 SQ-RX S-ICD Pulse Generator Model 1010 User Manual

Important Medical Device Information

Boston Scientific has released programmer software version 4.03 to address potential radio frequency (RF) interference that may cause unintended commands during wireless communication with the Model 3200 S-ICD programmer.

This behavior can occur during in-clinic interrogation/programming sessions and may alter temporary parameters without the user’s knowledge.

Recommendations

For EMBLEM S-ICDs, the new software resolves the potential for RF interference. For SQ-RX S-ICDs, recommendations include reducing the frequency of in-clinic checks, ensuring external defibrillation equipment and medical personnel are available, and minimizing the duration of programmer communications.

Physicians should confirm SQ-RX S-ICD settings by performing specific steps, including ending the original telemetry session, initiating a new session, and printing a device Summary Report.

Manual:

Download: EMBLEM S-ICD Model A209 and EMBLEM MRI S-ICD Model A219 SQ-RX S-ICD Pulse Generator Model 1010 User Manual

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