MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM MRI S-ICD; IMPLANTABLE DEVICE

Model Number A219

Device Problems No Audible Alarm (1019); Premature Discharge of Battery (1057); Interrogation Problem (4017)

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

Event Date 11/02/2022

Event Type  Injury  

Event Description

It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) had difficulty being interrogated during an s-icd replacement procedure for premature battery depletion.Tones were not being emitted with magnet application.The s-icd was successfully replaced with a new device, and the electrode remains in service.No additional adverse patient effects were reported.

Event Description

It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) had difficulty being interrogated during an s-icd replacement procedure for premature battery depletion.Tones were not being emitted with magnet application.The s-icd was successfully replaced with a new device, and the electrode remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this s-icd was thoroughly inspected and analyzed.A high current drain was detected.Detailed analysis confirmed the identified high current drain was a result of a compromised capacitor.This resulted in the observed premature battery depletion.It was determined that the capacitor was compromised due to the presence of excess hydrogen in the device case.Boston scientific issued a field safety notice regarding a subset of emblem devices that have a potential of exhibiting this behavior.This particular device is included in the emblem s-icd accelerated depletion advisory population.

• Brand Name: EMBLEM MRI S-ICD
• Type of Device: IMPLANTABLE DEVICE
• 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: 15802039
• MDR Text Key: 303699888
• Report Number: 2124215-2022-47322
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/29/2018
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 202817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0936-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male