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

Model Number A219

Device Problems Over-Sensing (1438); Failure to Convert Rhythm (1540); Failure to Sense (1559); Failure to Read Input Signal (1581)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2022

Event Type  malfunction  

Event Description

It was reported that during the implant procedure the subcutaneous implantable cardioverter defibrillator (s-icd) experienced difficulty converting the induced arrhythmia at 65 joules.Two induced shocks were given, however neither converted the induced arrhythmia due to incorrect defibrillation pad placement.An 80 joule rescue shock was given from the s-icd which successfully converted the arrhythmia.Sometime after the shocks, during the optimization the primary sensing vector was selected and showed completely flat sensing.An air bubble was thought to be the cause as proper placement of the products were verified.The physician planned to retest the sensing at a later date.Boston scientific technical services (ts) was consulted and reviewed the information.Ts discussed that further review of system placement and electrode insertion should be considered as subsequent findings show inappropriate sensing in all vectors.Shock impedance measurements of delivered shocks were within normal range.The field representative noted that 24 hours after the procedure another interrogation occurred and showed appropriate sensing.The physician believed that during the shocks an air bubble slid towards the xiphoid electrode.Isometric testing also showed appropriate sensing.The s-icd was left programmed to primary vector and the physician did not want to repeat defibrillation threshold (dft) testing as he believed the criteria of 80 joule shock was effective.Ts further re-iterated that lead insertion and system placement should be evaluated in this case.Ts also discussed that there is not currently a 15 joule safety margin documented as recommended per labeling, potentially impacting conversion efficacy of a subsequent ambulatory episode.Ts further noted that the second induction attempt was commanded with standard polarity.The commanded shock was given at reverse polarity.The s-icd and electrode remain in service and no adverse patient effects were reported.

Manufacturer Narrative

No additional information is available.If additional information becomes available the report will be updated at that time.

• 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: 14067566
• MDR Text Key: 289100752
• Report Number: 2124215-2022-05429
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P110042/S058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/10/2023
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 155060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2022
• Initial Date FDA Received: 04/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1