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

Model Number	K273
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A longevity calculation was completed and it was confirmed that the device did not meet longevity expectations.Device memory was reviewed and no faults or errors were noted.It was confirmed that the device was in ddd mode at the time the replacement indicator was declared.It was also noted that the device sensed in the atrial chamber 100% of the time while implanted with prolonged high atrial rates.The device was then exposed to simulated heart load conditions, and the pacing and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.Chronic high atrial rates, as occurred with this device, can reduce longevity in devices that are programmed ddd with atrial sensing on.Device power consumption increases proportional to the additional processing for sensed atrial events.As a result, the high rate of atrial sensing was determined to be the cause of the longevity being lower than expected.
Event or Problem Description
This product was returned to the manufacturer without any report of performance issues or adverse patient effects.The returned device was analyzed, and the product investigation result indicated that this device exhibited chronic high atrial sensing which affected the longevity.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this product was returned to the manufacturer without any report of performance issues or adverse patient effects.The returned device was analyzed, and the product investigation result indicated that this device exhibited chronic high atrial sensing which affected the longevity.There were no field allegations.Initial investigation noted a failed longevity calculation.Detailed analysis confirmed premature battery depletion based upon chronic high atrial rates reduce longevity in devices that are programmed ddd(r) and atrial sensing on.Atrial was sensing 100% of the time.Device power consumption increases, proportional to the additional processing for sensed atrial events.The longevity calculator does not account for this increased power.
Event or Problem Description
This product was returned to the manufacturer without any report of performance issues or adverse patient effects.The returned device was analyzed, and the product investigation result indicated that this device exhibited chronic high atrial sensing which affected the longevity.

• 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: 12271293
• Report Number: 2124215-2021-22604
• Device Sequence Number: 14763558
• Product Code: LWP
• UDI-Device Identifier: 00802526516962
• UDI-Public: 00802526516962
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2022

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: Other
• Device Expiration Date: 05/10/2015
• Device Model Number: K273
• Device Catalogue Number: K273
• Device Lot Number: 100246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 04/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2013
• 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
• Patient Sex: Female