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

Model Number	6498
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2022
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.
Event or Problem Description
It was reported that the communicator showed no lights and sparked.The communicator was power cycled but still no lights.The patient advocate tried another outlet but no light on communicator and communicator power cord.The patient advocate informed that the patient saw sparks coming from the communicator.A boston scientific company representative advised sending a replacement communicator.No adverse patient effects were reported.The communicator was deactivated.

• 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: 15127285
• Report Number: 2124215-2022-28109
• Device Sequence Number: 20250632
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/28/2022

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: 6498
• Device Catalogue Number: 6498
• Device Lot Number: 5004644
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male