MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number	G248
Medical Device Problem Codes	High impedance (1291); Over-Sensing (1438); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
It was reported that this device exhibited inappropriate atrial tachy response (atr) episodes.Further review found that the atr episodes were caused by oversensing of the minute ventilation signal.In addition, high out of range pace impedance spikes on the right atrial (ra) lead were observed to have been occurring intermittently since june.At this time, reprogramming was performed to resolve the oversensing and the system remains in service.The ra lead is another manufacturer's product.The patient is not dependent.No adverse patient effects were reported.
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
This supplemental report is being filed because the conclusion code was updated.

• Brand Name: VIGILANT X4 CRT-D
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8581353
• Report Number: 2124215-2019-08557
• Device Sequence Number: 16877725
• Product Code: NIK
• UDI-Device Identifier: 00802526589300
• UDI-Public: 00802526589300
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2019

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: Lay User/Patient
• Device Expiration Date: 03/07/2019
• Device Model Number: G248
• Device Catalogue Number: G248
• Device Lot Number: 375856
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR