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

Model Number A219

Device Problems Signal Artifact/Noise (1036); Delayed Charge Time (2586)

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

Event Date 02/28/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that defibrillation threshold (dft) testing was performed following the implant of the leadless pacemaker.The time to therapy was longer than expected, at 38 seconds, due to noise.The cause of the noise was not determined, but the shock was successfully delivered and the s-icd system remains implanted and in service with no adverse patient effects reported.

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.This report is being filed to correct the impact code and update the evaluation conclusion code.This correction report is being filed to add another impact code, f05, that was missed in the previous report.

Event Description

It was reported that defibrillation threshold (dft) testing was performed following the implant of the leadless pacemaker.The time to therapy was longer than expected, at 38 seconds, due to noise.The cause of the noise was not determined, but the shock was successfully delivered and the s-icd system remains implanted and in service with no adverse patient effects reported.

Manufacturer Narrative

If pertinent information is provided in the future, a supplemental report will be submitted.This report is being filed to correct the impact code and update the evaluation conclusion code.

Event Description

It was reported that defibrillation threshold (dft) testing was performed following the implant of the leadless pacemaker.The time to therapy was longer than expected, at 38 seconds, due to noise.The cause of the noise was not determined, but the shock was successfully delivered and the s-icd system remains implanted and in service with no adverse patient effects reported.

• 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: 16670928
• MDR Text Key: 312584813
• Report Number: 2124215-2023-15597
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526584404
• UDI-Public: 00802526584404
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110042/S058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/15/2022
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 136037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 77 YR
• Patient Sex: Male