LATITUDE Patient Management System Communicator, Model 6482. The LATITUDE Patient Management system is intended for use

FDA device recall Z-3183-2011 · posted 2011-09-09 · Terminated

Recall details

Recalling firm

Boston Scientific CRM Corp

Reason for recall

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

LWS

Quantity affected

2

Distribution

Nationwide Distribution-in the states of Florida and Texas.

Date initiated

2011-05-25

Date posted

2011-09-09

Date terminated

2012-12-04

Location

Saint Paul, MN