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

Model Number G148

Device Problems Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); High Capture Threshold (3266)

Patient Problem No Code Available (3191)

Event Date 01/11/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that this patient with this cardiac resynchronization therapy defibrillator (crt-d) system exhibited high right atrial (ra) impedance measurements, measuring greater than 2000 ohms, high threshold measurements, failure to capture and oversensing with no asystole.Subsequently, the ra lead was surgically abandoned and replaced.The crt-d remains in service.No additional adverse patient effects were reported.

• Brand Name: INOGEN X4 CRT-D
• Type of Device: 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: 11233725
• MDR Text Key: 228831259
• Report Number: 2124215-2021-02278
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/20/2018
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 159541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 73 YR