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

Model Number A219

Device Problems High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Inaccurate Synchronization (1609)

Patient Problems Cardiac Arrest (1762); Electric Shock (2554)

Event Date 04/05/2023

Event Type  Injury  

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

Event Description

It was reported that the patient arrived at the hospital in cardiac arrest and was intubated.The patient has a subcutaneous implantable cardioverter defibrillator (s-icd) implanted along with another manufacturer's cardiac resynchronization therapy pacemaker (crt-p) and epicardial leads in the abdomen.The epicardial leads appear to be the switched in the header as the unipolar right ventricle lead is connected in the left ventricle connector, and the bipolar left ventricle lead is connected in the right ventricle connector.Upon interrogation, the patient was in bi-ventricular pacing mode and the memory of the s-icd showed 11 shocks in seven episodes.The first five shocks were noted to be inappropriate and the last one of them induced the patient into ventricular fibrillation (vf).This arrhythmia was efficiently treated after four shocks in two different episodes.Therapy was exhausted in one of the episodes.X-ray was taken and new screening was performed to assess if a different location for the s-icd system would yield appropriate sensing.The screening passed in supine position using pacing bipolar mode.However, under the spontaneous rhythm the screening did not pass in any sensing vector due to low r to t ratios.It was further noted that there was high shock and system impedance.A revision procedure was performed where the s-icd and electrode were explanted.During the procedure it was noted that the system appeared to be more superficial with a subcutaneous pocket and no optimal lead placement.The new s-icd system was implanted with a new intermuscular pocket and a new vertical tunnelling.It was also placed higher and deeper than the previous system and yielded a good induction test along with within range measurements.No additional adverse patient effects were reported.

Event Description

It was reported that the patient arrived at the hospital in cardiac arrest and was intubated.The patient has a subcutaneous implantable cardioverter defibrillator (s-icd) implanted along with another manufacturer's cardiac resynchronization therapy pacemaker (crt-p) and epicardial leads in the abdomen.The epicardial leads appear to be the switched in the header as the unipolar right ventricle lead is connected in the left ventricle connector, and the bipolar left ventricle lead is connected in the right ventricle connector.Upon interrogation, the patient was in bi-ventricular pacing mode and the memory of the s-icd showed 11 shocks in seven episodes.The first five shocks were noted to be inappropriate and the last one of them induced the patient into ventricular fibrillation (vf).This arrhythmia was efficiently treated after four shocks in two different episodes.Therapy was exhausted in one of the episodes.X-ray was taken and new screening was performed to assess if a different location for the s-icd system would yield appropriate sensing.The screening passed in supine position using pacing bipolar mode.However, under the spontaneous rhythm the screening did not pass in any sensing vector due to low r to t ratios.It was further noted that there was high shock and system impedance.A revision procedure was performed where the s-icd and electrode were explanted.During the procedure it was noted that the system appeared to be more superficial with a subcutaneous pocket and no optimal lead placement.The new s-icd system was implanted with a new intermuscular pocket and a new vertical tunnelling.It was also placed higher and deeper than the previous system and yielded a good induction test along with within range measurements.No additional adverse patient effects were reported.

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Investigation of the available information determined this device's delivery of a shock may have contributed to unintentional induction of or acceleration of an arrhythmia.Please refer to the description for more information regarding the specific circumstances of this event.

• 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: 16761050
• MDR Text Key: 313494824
• Report Number: 2124215-2023-18215
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526584404
• UDI-Public: 00802526584404
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P110042/S058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/07/2018
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 204614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 67 YR