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

Model Number 6299

Device Problem Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2021

Event Type  malfunction  

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 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
• Type of Device: 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: 11721631
• MDR Text Key: 247238129
• Report Number: 2124215-2021-07089
• Device Sequence Number: 1
• Product Code: OSR
• UDI-Device Identifier: 00802526553516
• UDI-Public: 00802526553516
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910077/S138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Other
• Device Model Number: 6299
• Device Catalogue Number: 6299
• Device Lot Number: 1002089
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2021
• Initial Date FDA Received: 04/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1