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

Model Number	6299
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As no further information concerning this product 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 field representative mentioned that the communicator power cord has frayed wiring.No adverse patient effects were reported.

• Brand Name: LATITUDE CONSULT
• Common Device Name: EXTERNAL COMMUNICATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11721631
• Report Number: 2124215-2021-07089
• Device Sequence Number: 11870538
• Product Code: OSR
• UDI-Device Identifier: 00802526553516
• UDI-Public: 00802526553516
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P910077/S138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2021

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: Other
• Device Model Number: 6299
• Device Catalogue Number: 6299
• Device Lot Number: 1002089
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/24/2021
• Patient Sequence Number: 1