MAUDE Adverse Event Report: EXTERNAL MANUFACTURER COMMUNICATOR; ACCESSORY

Model Number 6496

Device Problem Computer Operating System Problem (2898)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2011

Event Type  malfunction  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, analysis of this communicator identified electrical overstress damage and a burn in the modem circuitry.Although a storm in the area was not reported, this is the most common cause of this type of damage.Due to the electrical overstress damage, no further testing was performed.The device manufacture date for this product is november 16, 2010.

Event Description

Boston scientific received information that this patient had issue with transmitting data since (b)(6) 2011.The patient was able to complete a patient initiated interrogated, but no data was visible on the website.An error code was noted and latitude customer support advices the patient to set up an alternative phone jack.It was noted that the patient received a dsl filter and was able to transmit data once again.No adverse patient effects were reported.

• Brand Name: COMMUNICATOR
• Type of Device: ACCESSORY
• Manufacturer (Section D): EXTERNAL MANUFACTURER
• Manufacturer (Section G): EXTERNAL MANUFACTURER
• Manufacturer Contact: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5852448
• MDR Text Key: 52658412
• Report Number: 2124215-2016-12959
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2016
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1