MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN X4 CRT-D; DEFIBRILLATOR, IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATION (CRT-D)

Model Number G148

Device Problem Failure to Capture (1081)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 09/25/2018

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system exhibited intermittent loss of capture on the right ventricular (rv) lead.The patient experienced greater than 2 seconds of asystole.There was no episodes with noise stored, and the representative was unable to produce any noise.Boston scientific technical services (ts) discussed reprogramming options.It was noted that the patient had started a new medication, and ts discussed seeing if that medication can impact thresholds.The physician elected to increase the rv sensitivity and increase the left ventricular (lv) lead output.This crt-d system remains in service.No adverse patient effects were reported.

• Brand Name: INOGEN X4 CRT-D
• Type of Device: DEFIBRILLATOR, IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATION (CRT-D)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CLONMEL LIMITED; cashel road; ,; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8006350
• MDR Text Key: 125099005
• Report Number: 2124215-2018-60476
• 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: Other
• Type of Report: Initial
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/27/2016
• Device Model Number: G148
• Device Catalogue Number: G148
• Device Lot Number: 127652
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/26/2018
• Initial Date FDA Received: 10/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2014
• 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 Age: 74 YR