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); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Data Problem (3196); Migration (4003)

Patient Problems Electric Shock (2554); Implant Pain (4561)

Event Date 02/28/2022

Event Type  Injury  

Manufacturer Narrative

This product is being evaluated in our post market quality assurance laboratory.This report will be updated when evaluation is complete.

Event Description

It was reported that one day post implant of this subcutaneous implantable cardioverter defibrillator (s-icd), a stored event was identified due to noise and odd deflections were noted on the presenting s-ecg.Episode review was performed by a boston scientific technical services consultant who confirmed the observed noise and extra deflections on the presenting data.The consultant recommended system troubleshooting.Additional information was received that there was a stored atrial fibrillation (af) episode.X-ray confirmed the device was in a slightly alternated position and migration was noted.It was noted that the device could not easily be located due to the large size of the patient.Some slight noise was observed during pocket manipulation and sternum maneuvers.The patient subsequently presented to the emergency room due to pocket pain.Another x-ray was performed which showed the device in a slightly lower position than the previous x-ray.The electrode body appeared to be curvy in nature.In clinic follow up testing was recommended; however, the patient did not show up for the appointment.The patient presented to the emergency room a second time after receiving a shock.Untreated episodes were also noted.Noise, non-physiologic artifact and oversensing were noted.The device was programmed to secondary vector and there was no observed noise during testing with the patient on her right side.The patient informed the boston scientific sales representative that she previously fell in her bedroom and landed on her right side.However, prior to the fall, the device was twisting and protruded out from her rib cage.She presented to the clinic at that time and was informed everything was fine.The patient will continue to be followed.No adverse patient effects were reported.It was reported that this system was subsequently explanted.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed.Visual inspection identified no anomalies.The device was able to be interrogated and a memory download was performed successfully.The device was then exposed to simulated heart load conditions, and the defibrillation and sensing functions were tested.The device operated appropriately, according to its performance specifications with no out of range measurements or interruptions in therapy output.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.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 one day post implant of this subcutaneous implantable cardioverter defibrillator (s-icd), a stored event was identified due to noise and odd deflections were noted on the presenting s-ecg.Episode review was performed by a boston scientific technical services consultant who confirmed the observed noise and extra deflections on the presenting data.The consultant recommended system troubleshooting.Additional information was received that there was a stored atrial fibrillation (af) episode.X-ray confirmed the device was in a slightly alternated position and migration was noted.It was noted that the device could not easily be located due to the large size of the patient.Some slight noise was observed during pocket manipulation and sternum maneuvers.The patient subsequently presented to the emergency room due to pocket pain.Another x-ray was performed which showed the device in a slightly lower position than the previous x-ray.The electrode body appeared to be curvy in nature.In clinic follow up testing was recommended; however, the patient did not show up for the appointment.The patient presented to the emergency room a second time after receiving a shock.Untreated episodes were also noted.Noise, non-physiologic artifact and oversensing were noted.The device was programmed to secondary vector and there was no observed noise during testing with the patient on her right side.The patient informed the boston scientific sales representative that she previously fell in her bedroom and landed on her right side.However, prior to the fall, the device was twisting and protruded out from her rib cage.She presented to the clinic at that time and was informed everything was fine.The patient will continue to be followed.No adverse patient effects were reported.It was reported that this system was subsequently explanted.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: 14978244
• MDR Text Key: 295628595
• Report Number: 2124215-2022-25022
• 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
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2023
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 152618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male