MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P; IMPLANTABLE PACEMANKER

Model Number U228

Device Problem Failure to Capture (1081)

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

Event Date 05/10/2021

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) system exhibited loss of capture (loc) in the left ventricular (lv) lead.The patient was scheduled for an in-clinic check and potential reprogramming.No adverse patient effects were reported.

• Brand Name: VISIONIST X4 CRT-P
• Type of Device: IMPLANTABLE PACEMANKER
• 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: 12113499
• MDR Text Key: 260449029
• Report Number: 2124215-2021-14599
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559471
• UDI-Public: 00802526559471
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030005/S138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/02/2021
• Device Model Number: U228
• Device Catalogue Number: U228
• Device Lot Number: 742333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2019
• 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: 95 YR