MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VITALIO; PACEMAKER

Model Number K274

Device Problems Failure to Capture (1081); Pacing Problem (1439); Under-Sensing (1661)

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

Event Date 02/05/2024

Event Type  malfunction  

Event Description

It was reported that the health care professional (hcp) called technical services (ts) and requested a review of the presenting electrogram (egm) of this pacemaker device.Upon review, ts noted a pattern of this pacemaker failing to capture some atrial paced signals due to undersensing of retrograde p-waves in the post-ventricular atrial refractory period (pvarp).Ts was unable to determine the onset of this pattern but after further review of the egm, ts suspected that the threshold tests in the right atrial auto threshold (raat) test may be the cause of the loss of capture (loc).Ts recommended device programming optimizations.The device remains in service.No adverse patient effects were reported.

• Brand Name: VITALIO
• Type of Device: 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: 18740750
• MDR Text Key: 335861372
• Report Number: 2124215-2024-10061
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N970003/S143
• 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: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/30/2016
• Device Model Number: K274
• Device Catalogue Number: K274
• Device Lot Number: 100524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2014
• 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: 99 YR
• Patient Sex: Female