MAUDE Adverse Event Report: EXTERNAL MANUFACTURER COMMUNICATOR; ACCESSORY

Model Number	6280
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Inadequate User Interface (2958)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.
Event or Problem Description
Boston scientific received information that the communicator was burnt and the communicator also affected the incoming and outgoing calls.A boston scientific company representative verified that there was a lightning storm that struck both the communicator and phone line and there was a spark from the area near the communicator where it was likely coming from the outlet where the communicator was connected.The patient informed the company representative that nobody was injured and the phone lines were eventually restored after unplugging the communicator.¿e company representative then sent a return label, a replacement communicator and a longer phone cord to the patient.The communicator was deactivated.No adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the allegation against the communicator was not determined as the communicator had pest infestation.The device was returned in a condition that made analysis impossible therefore analysis was unable to confirm the observation.

• Brand Name: COMMUNICATOR
• Common Device Name: ACCESSORY
• Manufacturer (Section D): EXTERNAL MANUFACTURER
• MDR Report Key: 6720707
• Report Number: 2124215-2017-11824
• Device Sequence Number: 919826
• Product Code: OSR
• UDI-Device Identifier: 00802526577307
• UDI-Public: (01)00802526577307(11)20160518
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 06/28/2017
• Supplement Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 07/18/2017
• Supplement Report FDA Received Date: 10/11/2017
• 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: 0293; E140
• Patient Age: 70 YR