MAUDE Adverse Event Report: EXTERNAL MANUFACTURER COMMUNICATOR; ACCESSORY

Model Number	6290
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2017
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 not working and had no lights.A boston scientific company representative verified that there was a recent electrical outage and also verified that the power cord has a steady light.The patient observed that there was a burning smell and the communicator was warm to the touch.The company representative had the patient unplugged the power cord from the power outlet.The company representative then ordered a communicator replacement and a return label was sent.Furthermore, the company representative verified that the patient had a new address.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 confirmed as the communicator had pest infestation.The product was returned in a condition that made analysis impossible therefore analysis was unable to confirm the observations.

• Brand Name: COMMUNICATOR
• Common Device Name: ACCESSORY
• Manufacturer (Section D): EXTERNAL MANUFACTURER
• MDR Report Key: 7168660
• Report Number: 2124215-2017-22463
• Device Sequence Number: 1823072
• Product Code: OSR
• UDI-Device Identifier: 00802526577451
• UDI-Public: 00802526577451
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 02/07/2018

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: 6290
• Other Device ID Number: LATITUDE WAVE COMMUNICATOR (MI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 03/21/2018
• 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: 3401; A209
• Patient Age: 54 YR