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

Model Number A219

Device Problems Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Displays Incorrect Message (2591)

Patient Problems Syncope (1610); Syncope/Fainting (4411)

Event Date 10/22/2019

Event Type  Injury  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, the clinically observed error message was confirmed.Memory review confirmed that the device underwent a reset due to memory corruption which resulted in the observed error message and premature battery depletion.The root cause of the memory corruption is unknown.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that interrogation of this device revealed a message indicating immediate device attention and end of life (eol) had been declared in 1987.A boston scientific technical services consultant discussed the clinical observations with the caller.It was also reported that this patient had a syncopal event but no shocks appear to have been given.The device was explanted due to a possible memory corruption.No additional adverse patient effects were reported.

Event Description

This supplemental report is being filed due to additional coding and manufacturer narrative.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, the clinically observed error message was confirmed.Memory review confirmed that the device underwent a reset due to memory corruption which resulted in the observed error message and premature battery depletion.The cause of the memory inconsistency was not able to be determined through laboratory testing but was likely the result of exposure to radiation, either therapeutic or environmental.This investigation will be updated should further information be provided.

• 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: 9570880
• MDR Text Key: 174366389
• Report Number: 2124215-2019-27802
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2021

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: Lay User/Patient
• Device Expiration Date: 08/17/2018
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 202104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 10/01/2021
• Supplement Dates FDA Received: 12/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0936-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female