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

Model Number U228

Device Problems Unexpected Therapeutic Results (1631); Under-Sensing (1661)

Patient Problem Ventricular Fibrillation (2130)

Event Date 06/22/2022

Event Type  Injury  

Manufacturer Narrative

This investigation will be updated should further pertinent information be provided.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) recorded events with confirmed ventricular tachycardia and ventricular fibrillation (vf), after reviewing the electrograms.At the presenting all the rv activity appears to be under sensed.Also, at other ventricular events, there is vf with small and intermittently under sensed signals.According to te field representative, in the middle of the night emergency personnel was dispatched to the residence of the patient but did not provide any further information as to pt outcome or if he was taken to a local hospital.The patient had a atrio-ventricular node ablation so the physician confirmed the arrhythmia was vf.The crt-p remains in service.No additional adverse patient effects were reported.

• Brand Name: VISIONIST 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: 14999034
• MDR Text Key: 295768889
• Report Number: 2124215-2022-25415
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559471
• UDI-Public: 00802526559471
• 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: Other
• Type of Report: Initial
• Report Date: 07/13/2022

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: 05/29/2021
• Device Model Number: U228
• Device Catalogue Number: U228
• Device Lot Number: 743373
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2019
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Male