MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VITALIO; IMPLANTABLE DEVICE

Model Number	K273
Medical Device Problem Codes	False Positive Result (1227); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	12/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient with a pacemaker presented to the emergency room (er) due to syncope.Technical services review the report and found there was low atrial intrinsic amplitude however, there was no oversensing observed.Additionally, there was a stored signal artifact monitoring (sam) episode in which the minute ventilation (mv) sensor was disabled and has not been turned back on.The sam episode appears to be false due to atrial fibrillation.The pacemaker did record an episode in the last 72 hours however, the cause the syncope is unknown.At this time, the pacemaker remains in service.No additional adverse patient effects were reported.

• Brand Name: VITALIO
• Common Device Name: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 12139513
• Report Number: 2124215-2021-18584
• Device Sequence Number: 14319919
• 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: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2021

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: 11/14/2016
• Device Model Number: K273
• Device Catalogue Number: K273
• Device Lot Number: 405565
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other