MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VITALIO?; Pacemaker

Model Number	K274
Medical Device Problem Codes	Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker entered safety mode and had recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Subsequently, it was explanted.A new device was implanted.No additional adverse patient effects were reported.

• Brand Name: VITALIO?
• Common Device Name: Pacemaker
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel E91 T 862; EI E91 T862
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50070240
• Report Number: 2124215-2026-40584
• Device Sequence Number: 10121250
• Product Code: LWP
• UDI-Device Identifier: 00802526536557
• UDI-Public: (01)00802526536557(17)160621
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: N970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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: 06/21/2016
• Device Model Number: K274
• Device Catalogue Number: K274
• Device Lot Number: 100650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 06/27/2014
• 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: Required Intervention; Hospitalization
• Patient Age: 89 YR
• Patient Sex: Female