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	11/02/2015
Type of Reportable Event	Malfunction
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
Boston scientific received information that this implantable cardioverter defibrillator (icd) and remote home monitoring system are in radiofrequency overuse.There is radiofrequency interference.A longevity calculation was performed from the device data and determined that the device has a shortened longevity due to the interference.Additional information was received indicating that the remote home monitor has been turned off and will only be turned on when used monthly.No adverse patient effects were reported.The device and remote home monitoring system remain in service.
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: 5636500
• Report Number: 2124215-2016-04848
• Device Sequence Number: 16202273
• Product Code: OSR
• UDI-Device Identifier: 00802526570209
• UDI-Public: (01)00802526570209
• Combination Product (Y/N): N
• PMA/510(K) Number: P910077/S140
• 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
• 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: 02/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2016
• Supplement Report FDA Received Date: 08/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4)
• Patient Age: 84 YR