MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM MRI S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number A219

Device Problems Over-Sensing (1438); Failure to Sense (1559); Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)

Patient Problem Electric Shock (2554)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device exhibited oversensing due to noise, with no conclusive evidence of a specific cause.Please see the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that the patient implanted with this subcutaneous implantable cardioverter defibrillator (s-icd) received two inappropriate shocks due to oversensing of noise.After the shock, the egm showed a flat line with no detection.The sense vector was primary, so the physician reprogrammed the device to the secondary vector.Device data was submitted to technical services for review, to see if the cause of the noise could be determined.No adverse patient effects were reported.The device remains implanted and in service.Technical services reviewed the episodes and confirmed the recorded episodes were caused by oversensing of high deflection amplitudes, baseline shifting, and temporary loss of the cardiac signal.Troubleshooting was recommended to see if the artifact could be reproduced with patient movements or device manipulation.If no artifacts could be created in the secondary vector, then the device should remain programmed to this vector.These kinds of artifacts are a result of sudden changes in the impedance pathway of the sensing vector.This can either be caused by incomplete lead insertion, an impaired lead, or other impairment of the lead contact in the device header, and is related to the sense b node (which is not used in sensing in secondary).It was noted that the secondary vector showed good sensing qualities.X-rays could be performed to evaluate the device header for complete electrode insertion.

• Brand Name: EMBLEM MRI S-ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 11263757
• MDR Text Key: 229805455
• Report Number: 2124215-2020-29212
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526584404
• UDI-Public: 00802526584404
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P110042/S058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/01/2021

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: 09/14/2020
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 235218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 02/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR