MAUDE Adverse Event Report: EXTERNAL MANUFACTURER COMMUNICATOR; ACCESSORY

Model Number	6280
Medical Device Problem Code	Inadequate User Interface (2958)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested.This report will be updated should additional information become available.
Event or Problem Description
Boston scientific received information that this remote home monitor and device are in radiofrequency overuse.Troubleshooting was performed which did slightly improve the overuse time.At this time, the radiofrequency overuse has had an impact on the device's battery longevity and will continue to do so if the radiofrequency overuse continues.The system remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
New information received indicates that the radiofrequency overuse has improved and is within an acceptable range.The overuse issue is considered resolved.No surgical intervention was performed and the device remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
The device manufacture date for this product is (b)(6) 2015.

• Brand Name: COMMUNICATOR
• Common Device Name: ACCESSORY
• Manufacturer (Section D): EXTERNAL MANUFACTURER
• MDR Report Key: 5636516
• Report Number: 2124215-2016-05603
• Device Sequence Number: 261323
• Product Code: OSR
• UDI-Device Identifier: 00802526570209
• UDI-Public: (01)00802526570209
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 6280
• Other Device ID Number: LATITUDE WAVE COMMUNICATOR (IS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/11/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/06/2016
• Supplement Report FDA Received Date: 07/18/2016; 08/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR