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); High impedance (1291); Over-Sensing (1438); Failure to Sense (1559); Inappropriate/Inadequate Shock/Stimulation (1574); Data Problem (3196)

Patient Problems Electric Shock (2554); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2022

Event Type  Injury  

Manufacturer Narrative

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 this subcutaneous implantable cardioverter defibrillator (s-icd) system exhibited no signal in primary vector and noise and out of range impedance in secondary vector.An impedance measurement was not produced during testing.A boston scientific technical services consultant discussed and offered explanations for the reported clinical observations.The consultant recommended performing a lateral x-ray to review the connection of the electrode into the device.The system was subsequently explanted.No additional adverse patient effects were reported.

Manufacturer Narrative

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 this subcutaneous implantable cardioverter defibrillator (s-icd) system exhibited no signal in primary vector and noise and out of range impedance in secondary vector.An impedance measurement was not produced during testing.A boston scientific technical services consultant discussed and offered explanations for the reported clinical observations.The consultant recommended performing a lateral x-ray to review the connection of the electrode into the device.The system was subsequently explanted.No additional adverse patient effects were reported.It was reported that the out of range impedance measurements was less than 30 ohms.An x-ray confirmed the electrode had dislodged which resulted in oversensing of noise and an inappropriate shock.No additional 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: 14107914
• MDR Text Key: 289249130
• Report Number: 2124215-2022-10621
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2022

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: 10/23/2023
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 152426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/13/2022
• Supplement Dates Manufacturer Received: 04/11/2022
• Supplement Dates FDA Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female