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 Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Boston scientific received information that the patient advocate called as the patient bumped into the table and the power cord exploded.The power cord was in an outlet with a quesadilla maker and waffle maker.The back of the communicator was ruined.There was no property damage, and no one was hurt due to the event.The company representative verified there were no power outage or electrical storm and an original power supply was used.The communicator was currently unplugged.The company representative advised for a communicator replacement.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, additional information was received that the allegation against the power adapter was confirmed.An electrical over stress (eos) occurred due to the power adapter issue.As there is no reportable allegation against the communicator itself and there was no serious injury, boston scientific no longer considers this to be a reportable event.This supplemental report is being filed to correct the b5: describe event or problem, g4: bsc aware date (additional information aware date), h3: device evaluation by manufacturer and device not eval by mfr code and h10: additional mfr narrative.
Event or Problem Description
It was reported that the patient advocate called as the patient bumped into the table and the power cord exploded.The power cord was in an outlet with a quesadilla maker and waffle maker.The back of the communicator was ruined.There was no property damage, and no one was hurt due to the event.The company representative verified there were no power outage or electrical storm and an original power supply was used.The communicator was currently unplugged.The company representative advised for a communicator replacement.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
• MDR Report Key: 8554631
• Report Number: 2124215-2019-07734
• Device Sequence Number: 2049295
• Product Code: LWS
• UDI-Device Identifier: 00802526554704
• UDI-Public: 00802526554704
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P910077/S119
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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: 5065459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 04/30/2020
• Patient Sequence Number: 1