MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number U228

Device Problems Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2019

Event Type  malfunction  

Event Description

It was reported that a low voltage alert, code 1003, was recorded on this device pre-implant.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.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated.

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 Description

It was reported that a low voltage alert, code 1003, was recorded on this device pre-implant.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.

• Brand Name: VISIONIST X4 CRT-P
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9211120
• MDR Text Key: 163008707
• Report Number: 2124215-2019-21605
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559471
• UDI-Public: 00802526559471
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/02/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2020
• Device Model Number: U228
• Device Catalogue Number: U228
• Device Lot Number: 734329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/18/2019
• Supplement Dates Manufacturer Received: 12/21/2019
• Supplement Dates FDA Received: 02/02/2020
• Patient Sequence Number: 1