MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VITALIO; PACEMAKER

Model Number	K273
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this pacemaker system is approved for magnetic resonance imaging (mri).However, it was noted that they performed an mri.Post-mri the technician indicates that the old leads fraying and the wires are poking through the insulation.The patient was referred to their clinic due to the statements mentioned.No adverse patient effects were reported related to the off-label use.Subsequently, a revision procedure was performed and the pacemaker was explanted and one part of one of the lead was surgically abandoned.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this pacemaker system is approved for magnetic resonance imaging (mri).However, it was noted that they performed an mri.Post-mri the technician indicates that the old leads fraying and the wires are poking through the insulation.The patient was referred to their clinic due to the statements mentioned.No adverse patient effects were reported related to the off-label use.Subsequently, a revision procedure was performed and the pacemaker was explanted and one part of one of the lead was surgically abandoned.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Impedance testing, pacing and sensing were completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

• 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 ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 20047134
• Report Number: 2124215-2024-52580
• Device Sequence Number: 20826000
• Product Code: LWP
• UDI-Device Identifier: 00802526516962
• UDI-Public: 00802526516962
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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: 05/10/2015
• Device Model Number: K273
• Device Catalogue Number: K273
• Device Lot Number: 100257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2013
• 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: Required Intervention; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Male