MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VITALIO; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number	K273
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker exhibited low out of range pacing impedance on the right atrial (ra) channel.The cause of the low out of range impedance is unknown.The device was explanted and replaced.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this pacemaker exhibited low out of range pacing impedance on the right atrial (ra) channel.The cause of the low out of range impedance is unknown.The device was explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent fluctuations in impedance measurements with no conclusive evidence of a product malfunction; please refer to the description for more information regarding the specific circumstances of this event.
Event or Problem Description
It was reported that this pacemaker exhibited low out of range pacing impedance on the right atrial (ra) channel.The cause of the low out of range impedance is unknown.The device was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: VITALIO
• Common Device Name: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 17459419
• Report Number: 2124215-2023-41521
• Device Sequence Number: 16818983
• Product Code: LWP
• UDI-Device Identifier: 00802526516962
• UDI-Public: 00802526516962
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/25/2015
• Device Model Number: K273
• Device Catalogue Number: K273
• Device Lot Number: 100865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 08/08/2023; 08/18/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 08/08/2023; 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2013
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female