MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LATITUDE COMMUNICATOR; EXTERNAL COMMUNICATOR

Model Number	6476
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the communicator power cord was hot, emitting smoke and was sparking.The communicator was for replacement and will be returned for analysis.No adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, additional information from product investigation indicates a pest-infested communicator.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, additional information from product investigation indicates a pest-infested communicator.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the communicator power cord was hot, emitting smoke and was sparking.The communicator was for replacement and will be returned for analysis.No adverse patient effects were reported.

• Brand Name: LATITUDE COMMUNICATOR
• Common Device Name: EXTERNAL COMMUNICATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 13467430
• Report Number: 2124215-2022-01431
• Device Sequence Number: 17134673
• Product Code: LWS
• UDI-Device Identifier: 00802526516115
• UDI-Public: 00802526516115
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P910077/S090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2022

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: 6476
• Device Catalogue Number: 6476
• Device Lot Number: 299147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 02/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female