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 Pacing Problem (1439); Under-Sensing (1661); Data Problem (3196); High Capture Threshold (3266)

Patient Problem Loss of consciousness (2418)

Event Date 01/24/2024

Event Type  Injury  

Event Description

It was reported that electrogram (egm) review was requested for this cardiac resynchronization therapy pacemaker (crt-p) system due ventricular fibrillation (vf) undersensing concerns.It was suspected there was inappropriate pacing into fine polymorphic ventricular tachycardia (pvt), as t-waves were visible when the device paced.Additionally, the patient passed out in the hospital.Upon review, technical services (ts) noted intermittent right ventricular (rv) undersensing.There was also a concern with the device clock as the patient passed out one hour apart from the stored episode, and it was discussed that the time discrepancy was likely attributed to daylight savings time.Right ventricular automatic threshold (rvat) was set to trend at 3v, and there was no evidence of loss of capture (loc).The highest threshold measurement was 2.3v and sensitivity was set to 2.5mv.Some stored pacemaker mediated tachycardia (pmt) episodes were noted, but appeared to be sinus tracking.This crt-p remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.

• 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
• 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: 18664757
• MDR Text Key: 334832801
• Report Number: 2124215-2024-07064
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S138
• 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
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/03/2022
• Device Model Number: U228
• Device Catalogue Number: U228
• Device Lot Number: 751412
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2020
• 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 Outcome(s): Other
• Patient Age: 77 YR
• Patient Sex: Male