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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 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 12/05/2016
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 had no lights.A boston scientific company representative was informed that the communicator was plugged into power.The patient also noted that the power supply was very warm to touch and was broken.The company representative advised the patient to unplug the power cord.The power cord was replaced.A return label was sent to the patient address.The communicator remains in service.No adverse patient effects were reported.
 
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Brand Name
COMMUNICATOR
Common Device Name
ACCESSORY
Manufacturer (Section D)
EXTERNAL MANUFACTURER
MDR Report Key6283352
Report Number2124215-2016-21579
Device Sequence Number16420390
Product Code OSR
UDI-Device Identifier00802526577451
UDI-Public(01)00802526577451(11)20160315
Combination Product (Y/N)N
Initial Reporter StateCA
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
Report Date (Section B) 12/05/2016
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 Number6290
Other Device ID NumberLATITUDE 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 12/05/2016
Initial Report FDA Received Date01/27/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
4137; 4470; L321
Patient Age69 YR
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