MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VITALIO; PACEMAKER

Model Number K274

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439)

Patient Problem Asystole (4442)

Event Date 01/01/2019

Event Type  malfunction  

Event Description

It was reported that this pacemaker exhibited noise and oversensing on both the right ventricular (rv) and right atrial (ra) leads which led to inappropriate atrial tachycardia response (atr) episodes and pacing inhibition greater than 2 seconds.Troubleshooting options were discussed and reprogramming efforts were performed.At this time, the pacemaker system remains in service and no additional adverse patient effects were reported.

Event Description

It was reported that this pacemaker exhibited noise and oversensing on both the right ventricular (rv) and right atrial (ra) leads which led to inappropriate atrial tachycardia response (atr) episodes and pacing inhibition greater than 2 seconds.Troubleshooting options were discussed and reprogramming efforts were performed.Additionally, it was observed high out-of-range pacing impedance measurements on both leads.At this time, the pacemaker system remains in service and no additional 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: 16045658
• MDR Text Key: 308010513
• Report Number: 2124215-2022-54877
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526536557
• UDI-Public: 00802526536557
• 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,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/25/2017
• Device Model Number: K274
• Device Catalogue Number: K274
• Device Lot Number: 409450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2015
• 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: 79 YR
• Patient Sex: Female