MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

Model Number U128

Device Problems Over-Sensing (1438); Pacing Problem (1439)

Patient Problem Syncope/Fainting (4411)

Event Date 01/02/2023

Event Type  malfunction  

Event Description

It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) had a syncopal episode while using an electrical razor.Pacing inhibition is suspected.A signal artifact monitor (sam) likely due to external noise was recorded.The patient went to the hospital after the syncopal episode.System parameters showed within range measurements.This crt-p remains in service.No adverse patient effects were reported.

Event Description

It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) had a syncopal episode while using an electrical razor.Pacing inhibition is suspected.A signal artifact monitor (sam) likely due to external noise was recorded.The patient went to the hospital after the syncopal episode.System parameters showed within range measurements.This crt-p remains in service.No adverse patient effects were reported.This device has not been returned; therefore, technical analysis cannot be conducted.Investigation of the available information determined this device exhibited incorrect categorization of atrial arrhythmia(s) as mv noise.

• Brand Name: VALITUDE X4 CRT-P
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER
• 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: 18198501
• MDR Text Key: 328901139
• Report Number: 2124215-2023-66363
• Device Sequence Number: 1
• Product Code: NKE
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/20/2018
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 710666
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2016
• 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: 86 YR
• Patient Sex: Male