MAUDE Adverse Event Report: EXTERNAL MANUFACTURER COMMUNICATOR; ACCESSORY

Model Number	6290
Medical Device Problem Codes	Computer Operating System Problem (2898); Inadequate User Interface (2958)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2016
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.The manufacture date for this product is april 30, 2015.
Event or Problem Description
Boston scientific received information that the estimated longevity for the device decreased more quickly than expected.Analysis of device data revealed that higher power consumption periods correlated with radio frequency (rf) overuse, which indicates that the device used more time than expected to communicate with the communicator.The patient was contacted to discuss methods to minimize rf interference.This communicator remains in service.No adverse patient effects reported.

• Brand Name: COMMUNICATOR
• Common Device Name: ACCESSORY
• Manufacturer (Section D): EXTERNAL MANUFACTURER
• MDR Report Key: 5844743
• Report Number: 2124215-2016-12746
• Device Sequence Number: 466153
• Product Code: OSR
• UDI-Device Identifier: 00802526570322
• UDI-Public: (01)00802526570322
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 05/25/2016

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: 6290
• Other Device ID Number: LATITUDE WAVE COMMUNICATOR (MI
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2016
• Initial Report FDA Received Date: 08/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR