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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXTERNAL MANUFACTURER COMMUNICATOR; ACCESSORY
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EXTERNAL MANUFACTURER COMMUNICATOR; ACCESSORY Back to Search Results
Model Number 6476
Medical Device Problem Code Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/16/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
 
Event or Problem Description
Boston scientific received information that the communicator was smoking.Communicator was deactivated and replaced.No adverse patient effects were reported.
 
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory it was confirmed product had pest infestation, therefore no analysis was able to be completed.
 
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Brand Name
COMMUNICATOR
Common Device Name
ACCESSORY
Manufacturer (Section D)
EXTERNAL MANUFACTURER
MDR Report Key7662649
Report Number2124215-2018-09548
Device Sequence Number14110834
Product Code LWS
UDI-Device Identifier00802526516115
UDI-Public00802526516115
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Patient
Type of Report Initial,Followup
Report Date (Section B) 05/25/2018
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 Expiration Date11/01/2015
Device Model Number6476
Other Device ID Number---
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2018
Was the Report Sent to FDA? Yes
Initial Date Received by Manufacturer 05/25/2018
Supplement Date Received by Manufacturer05/25/2018
Initial Report FDA Received Date07/04/2018
Supplement Report FDA Received Date07/04/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age54 YR
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