| Date Posted |
March 01, 2012 |
| Recall Number |
Z-1135-2012 |
| 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, Minnesota 55112-5700 |
| Consumer Instructions |
Contact the recalling firm for information |
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
|
| 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. |
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