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); Unexpected Therapeutic Results (1631)

Patient Problem Fall (1848)

Event Date 04/09/2023

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 this patient with this subcutaneous implantable cardioverter defibrillator (s-icd) experienced ventricular tachycardia (vt) and received multiple shocks within 2 days.Technical services (ts) reviewed and noted the therapy was appropriately delivered however was delayed due to noise that was observed.This patient had fallen out of bed after one of the episodes and subsequently has been hospitalized.Ts recommended isometrics testing to look for noise with the goal of choosing a better vector.This s-icd remains in service.No adverse patient effects were reported.

Event Description

It was reported that this patient with this subcutaneous implantable cardioverter defibrillator (s-icd) experienced ventricular tachycardia (vt) and received multiple shocks within 2 days.Technical services (ts) reviewed and noted the therapy was appropriately delivered however was delayed due to noise that was observed.This patient had fallen out of bed after one of the episodes and subsequently has been hospitalized.Ts recommended isometrics testing to look for noise with the goal of choosing a better vector.This s-icd remains in service.No adverse patient effects were 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: 16773718
• MDR Text Key: 313629763
• Report Number: 2124215-2023-18823
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526584404
• UDI-Public: 00802526584404
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2023

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: Lay User/Patient
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 170249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 04/19/2023
• Supplement Dates Manufacturer Received: 05/22/2023
• Supplement Dates FDA Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2022
• 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
• Patient Age: 38 YR
• Patient Sex: Male