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

Model Number G148

Device Problem Failure to Convert Rhythm (1540)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/06/2023

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) presented to the emergency room due to shock therapy delivery.The patient is known for ventricular tachycardia (vt) episodes and vt ablation had been performed in the past.The device delivered 6 ineffective anti-tachycardia pacing (atp) before delivering one 31 joule effective shock.The physician decided to change the programming by reducing the duration in vt-1 and vt zones and changing the atp to only 3 schaumann schemes in both vt-1 and vt zones.The patient was hospitalized to monitor the clinical condition.The plan is to enroll the patient in latitude home monitoring system.No additional adverse patient effects were reported.This device and electrode remain in-service.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Please refer to b5 describe event or problem for more information regarding the specific circumstances of this event.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) presented to the emergency room due to shock therapy delivery.The patient is known for ventricular tachycardia (vt) episodes and vt ablation had been performed in the past.The device delivered 6 ineffective anti-tachycardia pacing (atp) before delivering one 31 joule effective shock.The physician decided to change the programming by reducing the duration in vt-1 and vt zones and changing the atp to only 3 schaumann schemes in both vt-1 and vt zones.The patient was hospitalized to monitor the clinical condition.The plan is to enroll the patient in latitude home monitoring system.No additional adverse patient effects were reported.This device remains in-service.

• Brand Name: INOGEN X4 CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• 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: 17393389
• MDR Text Key: 319791495
• Report Number: 2124215-2023-39448
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/25/2018
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 159653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other