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 Signal Artifact/Noise (1036); Over-Sensing (1438); Failure to Read Input Signal (1581)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2024

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited right atrial (ra) lead noise with oversensing.Review of the presenting electrogram (egm) showed two signals, one small signal followed by a larger signal that looked like a true p-wave.Review of ra lead trends showed low amplitude p-waves as small as 0.3 mv with other measurements around 2.5-3 mv.Technical services (ts) discussed troubleshooting options, programming considerations, and possible causes.It was noted that the patient had a history of atrial fibrillation (af) and x-rays showed that the ra lead was low, on the right side, and near the valve.There were no known ablations or other cardiac procedures outside of the device implant.The patient was scheduled for a office visit on the day of report and the plan was to address these observations via reprogramming.This crt-p system remains in service.No 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: 18890009
• MDR Text Key: 337530655
• Report Number: 2124215-2024-14961
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: U228
• Device Catalogue Number: U228
• Device Lot Number: 777419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• 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: 70 YR
• Patient Sex: Male