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); Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581); Migration (4003)

Patient Problem Electric Shock (2554)

Event Date 09/07/2021

Event Type  Injury  

Event Description

It was reported that the patient received an inappropriate shock due to oversensing of noise.The patient stated the pulse generator has moved lower.The shock impedance was high at 111 ohms and the smart pass feature could not be programmed on due to reduced intrinsic amplitudes.Also, the patient was experiencing pocket stimulation.The pulse generator was explanted and replaced using the same electrode.There were no additional adverse patient effects.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, the device was examined.Visual inspection noted no damage.The device was then exposed to simulated heart load conditions, and the defibrillation functions were tested.The device operated appropriately, according to its performance specifications with no interruptions in therapy output or programmer communication at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.The laboratory analysis confirmed normal device function.

Event Description

This supplemental report is being filed to provide additional information regarding product analysis.It was reported that the patient received an inappropriate shock due to oversensing of noise.The patient stated the pulse generator has moved lower.The shock impedance was high at 111 ohms and the smart pass feature could not be programmed on due to reduced intrinsic amplitudes.Also, the patient was experiencing pocket stimulation.The pulse generator was explanted and replaced using the same electrode.There were no additional adverse patient effects.

• 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: 12610912
• MDR Text Key: 276117840
• Report Number: 2124215-2021-28860
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/22/2019
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 211303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2017
• 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: 47 YR
• Patient Sex: Female