MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; IMPLANTABLE DEVICE

Model Number U128

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Patient Involvement (2645)

Event Date 03/12/2020

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker recorded a pre-implant 1003 code indicative of battery voltage too low for the projected remaining capacity.This device is not cleared for implant yet.There was no patient involvement at the time of this issue.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker recorded a pre-implant 1003 code indicative of battery voltage too low for the projected remaining capacity, presumed to be due to cold weather.Technical services confirmed with engineering that this device is now cleared for implant.There is no patient involvement at the time of this issue.

Manufacturer Narrative

This correction report is being submitted to inform the complaint is no longer considered reportable as this device has been now cleared for implant.

• Brand Name: VALITUDE X4 CRT-P
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9982016
• MDR Text Key: 188381414
• Report Number: 2124215-2020-08585
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: 00802526559402
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/09/2020
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 736510
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2020
• Patient Sequence Number: 1