MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VITALIO; PACEMAKERS

Model Number	K272
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this patient with this pacemaker device exhibited t wave oversensing since last few months now.The patient had history of rapid ventricular response (rvr) and non-sustained episodes were noted on the presenting.Upon further review of the episodes, it looked like intermittent t wave oversensing.Technical services (ts) discussed options for optimizing sensitivity, retractor as much as possible to minimize twos and option of adjusting tachy detection as appropriate.This device remains in service, no adverse patient effects were reported.

• Brand Name: VITALIO
• Common Device Name: PACEMAKERS
• 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: 17780863
• Report Number: 2124215-2023-51380
• Device Sequence Number: 6634078
• Product Code: LWP
• UDI-Device Identifier: 00802526516955
• UDI-Public: 00802526516955
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/16/2017
• Device Model Number: K272
• Device Catalogue Number: K272
• Device Lot Number: 173312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Male