FDA Device

LATITUDE Patient Management System Communicator, Model 6482. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and transfer data to a central database.

Hazard

Boston Scientific has identified two occurrences where the LATITUDE system did not process a data payload, which is the information uploaded to the LATITUDE system from a remote interrogation of the implanted device. These occurrences resulted in non-displayed payloads because the data is not posted to the website. If the payload is not displayed, the pertinent data will not be available on the

What You Should Do

Remedy

Boston Scientific notified all affected customers by telephone on May 25, 2011. The customers were informed that there was an interrogation for one of their patients that was not able to be displayed on the website. Boston Scientific detected that a payload failure had occurred, but could not conclude what information was contained within the payload. Each patient has had previous and subsequent payloads that have processed and displayed on the LATITUDE website.

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Products

LATITUDE Patient Management System Communicator, Model 6482. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Boston Scientific pulse generator and
Brand
Boston Scientific CRM Corp
UPC
SN 035074 SN 032915

Units Affected

2

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