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

Model Number G141

Device Problems Failure to Capture (1081); High impedance (1291); Off-Label Use (1494); Connection Problem (2900); Device Sensing Problem (2917)

Patient Problem Dyspnea (1816)

Event Date 01/22/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during a procedure to implant this patient with this new cardiac resynchronization therapy defibrillator (crt-d), the device and the patient's chronic right ventricular (rv) defibrillation lead exhibited shock impedance measurements of greater than 200 ohms.The rv sensing was also low, and the shock electrogram (egm) looked different when the shock impedances were being tested.Technical services (ts) discussed several troubleshooting options.The procedure was completed and it was planned to check the patient in one week.The patient presented for follow up and was having symptoms of shortness of breath.The shock impedance measurements remained greater than 200 ohms, there was no left ventricular (lv) capture, and there was an issue with sensing.It was suspected that the leads were reversed in the header.A surgical revision was performed, and it was confirmed that one of the defibrillation portions of the rv lead was in the wrong port of the device.It was also found that the atrial and left ventricular (lv) leads were reversed in the header.This was corrected with no further issues.No additional adverse patient effects were reported.The device remains in service.

• Brand Name: INOGEN 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: 11356248
• MDR Text Key: 232843258
• Report Number: 2124215-2021-03496
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534553
• UDI-Public: 00802526534553
• 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: 02/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2022
• Device Model Number: G141
• Device Catalogue Number: G141
• Device Lot Number: 142551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR