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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 Device Recall LATITUDE Patient Management System Communicator see related information
Date Initiated by Firm January 19, 2012
Date Posted March 01, 2012
Recall Status1 Terminated 3 on July 05, 2012
Recall Number Z-1135-2012
Recall Event ID 61107
PMA Number P910077S110 
Product Classification Implantable cardioverter defibrillator (non-crt) - Product Code LWS
Product Boston Scientific, LATITUDE¿ Patient Management System Communicator, Models 6476.

The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database.
Code Information SN 224453
Recalling Firm/
Manufacturer		 Boston Scientific CRM Corp
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information Contact
651-582-4000
Manufacturer Reason
for Recall		 One (1) Model 6476 LATITUDE Communicator is unable to interrogate the patient's pulse generator. Boston Scientific has determined that this is due to a patient receiving an incorrect communicator. Therefore the communicator did not find and was unable to interrogate the assigned patients PG. Additionally when the patient attempted to set-up this incorrect communicator, the system reflected
FDA Determined
Cause 2		 Packaging process control
Action On January 19, 2012 Boston Scientific telephoned the affected patient and their clinic. The patient was notified that the communicator they received will not be able to activate successfully and that their communicator and sensors would be replaced. The clinician was informed of the patient's communicator was sent incorrectly to the other patient who attempted to activate it, the monitored status of the website was incorrect and that a new communicator would be shipped to the patient that will work with their device.
Quantity in Commerce 1
Distribution Nationwide distribution: UT only.
Total Product Life Cycle TPLC Device Report
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.
PMA Database PMAs with Product Code = LWS and Original Applicant = BOSTON SCIENTIFIC
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