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

Model Number G148

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Endocarditis (1834); Unspecified Infection (1930); Sepsis (2067); Respiratory Failure (2484)

Event Date 05/25/2023

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) had exhibited infection.Reportedly, the patient had endocarditis with vegetation identified on the lead and the patient had been in respiratory failure and septic shock.A revision was performed and the crt-d along with the right ventricular (rv) lead, right atrial (ra) lead and non-bsc left ventricular (lv) lead were explanted.No additional adverse patient effects were reported.This crt-d will be returned for analysis.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual inspection found no irregularities that would have been present when the customer received or utilized the device, and the header was firmly attached.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was 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 of the returned product is not able to provide relevant information for infection-related allegations.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) had exhibited infection.Reportedly, the patient had endocarditis with vegetation identified on the lead and the patient had been in respiratory failure and septic shock.A revision was performed and the crt-d along with the right ventricular (rv) lead, right atrial (ra) lead and non-bsc left ventricular (lv) lead were explanted.No additional adverse patient effects were reported.This crt-d will be returned for analysis.

• 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: 17109637
• MDR Text Key: 316984720
• Report Number: 2124215-2023-30071
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534591
• UDI-Public: 00802526534591
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/27/2016
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 109062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male