MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; IMPLANTABLE DEVICE

Model Number	G248
Medical Device Problem Codes	High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Convert Rhythm (1540); Under-Sensing (1661)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	07/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cardiac resynchronization therapy pacemaker (crt-p) device delivered six shocks resulting in therapy exhaustion.This patient then experienced a syncopal episode in which the emergency medical technician (emt) had to provide three external shocks to successfully convert the patient.This system exhibited high out-of- range shock lead impedances resulting in a recorded code 1005.Review of the electrogram shows the patient was in ventricular tachycardia (vt) and ventricular fibrillation (vf) in which the device appropriately provided therapy.The rhythm got super fine after the atp and with some undersensing noted.The patient was then transported to the intensive care unit.Technical services discussed programming optimization.At this time, this system remains in service.No additional adverse patient effects were reported.

• Brand Name: VIGILANT X4 CRT-D
• Common Device Name: IMPLANTABLE DEVICE
• 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: 15008018
• Report Number: 2124215-2022-25545
• Device Sequence Number: 19425087
• Product Code: NIK
• UDI-Device Identifier: 00802526589300
• UDI-Public: 00802526589300
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012/S436
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2022

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: 05/04/2019
• Device Model Number: G248
• Device Catalogue Number: G248
• Device Lot Number: 376579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2017
• 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: Hospitalization; Other
• Patient Age: 62 YR
• Patient Sex: Male