Date Initiated by Firm | May 25, 2011 |
Date Posted | September 09, 2011 |
Recall Status1 |
Terminated 3 on December 04, 2012 |
Recall Number | Z-3183-2011 |
Recall Event ID |
59421 |
PMA Number | P910077S051 |
Product Classification |
Implantable cardioverter defibrillator (non-crt) - Product Code LWS
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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 MN 55112-5700
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For Additional Information Contact | 651-582-4000 |
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 | 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database | PMAs with Product Code = LWS
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