MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST CRT-P; IMPLANTABLE DEVICE

Model Number	U226
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.
Event or Problem Description
It was reported that this device recorded a code 1003 during pre-implant interrogation due to an unknown reason.The device was interrogated again, but the alert was unable to be cleared.No patient involvement.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, it was noted that the device was returned in the original sterile packaging.An evaluation of the device was performed.Review of the device memory confirmed that a low voltage alert, code 1003, was recorded and that the device recorded low temperature readings prior to setting the low voltage alert.If this model device is stored in environments where temperatures can drop below the recommended storage temperature, battery voltage readings that are low enough to set a low voltage alert may result.This appears to be the case with this device.The battery did recover after the device was removed from the cold.
Event or Problem Description
This supplemental report is being filed to include the product investigation details.

• Brand Name: VISIONIST CRT-P
• Common Device Name: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8722880
• Report Number: 2124215-2019-10474
• Device Sequence Number: 2022560
• Product Code: NKE
• UDI-Device Identifier: 00802526559457
• UDI-Public: 00802526559457
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030005/S138
• 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): 10/17/2019

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 Expiration Date: 04/23/2020
• Device Model Number: U226
• Device Catalogue Number: U226
• Device Lot Number: 700791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 10/17/2019
• Patient Sequence Number: 1