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

Model Number U125

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439)

Patient Problem Insufficient Information (4580)

Event Date 02/27/2021

Event Type  malfunction  

Event Description

It was reported that two signal artifact monitoring (sam) episodes were stored with this cardiac resynchronization therapy pacemaker (crt-p) in which the minute ventilation (mv) sensor was disabled.Technical services reviewed the following electrogram and found noise on both the right atrial (ra) and right ventricular (rv) channels which resulted in a pause in pacing that was greater than two seconds.Technical services suspects this was due to electromagnetic interference (emi).Additionally, it was noted there was one out-of-range pacing impedances on the non-boston scientific rv lead.At this time, this crt-p and non-boston scientific rv remains in service.No adverse patient effects were reported.

• Brand Name: VALITUDE CRT-P
• Type of Device: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 11669083
• MDR Text Key: 245508813
• Report Number: 2124215-2021-06789
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559389
• UDI-Public: 00802526559389
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/13/2021
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 714148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 41 YR