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

Model Number G148

Device Problems High impedance (1291); Noise, Audible (3273)

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

Event Date 03/05/2024

Event Type  malfunction  

Event Description

It was reported that the patient reported hearing tones from their cardiac resynchronization therapy defibrillator (crt-d).Upon interrogation the crt-d and right ventricular (rv) lead exhibited shock impedance measurements varying from around 135 ohms to 153 ohms.The tones were due to measurements greater than 150 ohms.The maximum limit was reset from 150 ohms to 175 ohms.This decision was made since all other measurements were within range, the patient is not pacemaker dependent and to date, the crt-d has not delivered any tachycardia therapy.Technical services (ts) was consulted and discussed troubleshooting steps in order to ensure integrity of the system.At this time the clinic has opted to continue to follow the patient remotely and will perform a follow-up in clinic in a few months.The crt-d and rv lead remain in service and no adverse effects were reported.

Manufacturer Narrative

No additional information is available.If additional information becomes available the report will be updated at that time.

• 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: 18951492
• MDR Text Key: 338261663
• Report Number: 2124215-2024-17236
• 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: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/16/2017
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 128859
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1