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

Model Number	6498
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the communicator plug was getting over heated and cracked.A boston scientific company representative advised the patient to replace the communicator.A return label was sent.No adverse patient effects were reported.
Event or Problem Description
It was reported that the communicator plug was getting over heated and cracked.A boston scientific company representative advised the patient to replace the communicator.A return label was sent.No adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.Upon receipt at our post market quality assurance laboratory additional information from product investigation indicates that the communicator was observed to have experienced electrical overstress (eos).Product analysis confirmed the that a melted plastic around the communicator prong was noted and fell out when the power adapter was removed from an outlet.

• Brand Name: LATITUDE COMMUNICATOR
• Common Device Name: EXTERNAL COMMUNICATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11218877
• Report Number: 2124215-2020-28476
• Device Sequence Number: 2947479
• Product Code: LWS
• UDI-Device Identifier: 00802526554704
• UDI-Public: 00802526554704
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P910077/S119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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: 6498
• Device Catalogue Number: 6498
• Device Lot Number: 5045541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 06/24/2021
• Patient Sequence Number: 1
• Patient Age: 82 YR