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U.S. Department of Health and Human Services

Class 2 Device Recall LATITUDE Patient Management System Communicator

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 Class 2 Recall
LATITUDE Patient Management System Communicator
see related information
Date Posted September 09, 2011
Recall Status1 Terminated on December 04, 2012
Recall Number Z-3183-2011
Recall Event ID 59421
Premarket Approval
PMA Number
P910077/S051
Product Classification Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
Product 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.
Code Information SN 035074 SN 032915
Recalling Firm/
Manufacturer
Boston Scientific CRM Corp
4100 Hamline Ave N
Saint Paul, Minnesota 55112-5700
Manufacturer 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
FDA Determined
Cause 2
DESIGN: Device Design
Action 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.
Quantity in Commerce 2
Distribution Nationwide Distribution-in the states of Florida and Texas.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LWS and Applicant = GUIDANT CORP.
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