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

Model Number A219

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917); Unintended Electrical Shock (4018)

Patient Problem Ventricular Fibrillation (2130)

Event Date 08/05/2019

Event Type  Injury  

Event Description

It was reported that when the patient was working with electrical equipment, they received an inappropriate shock.Boston scientific technical services was contacted which confirmed that the inappropriate shock due to t-wave oversensing (twos) and very low in amplitude signals from the r-wave.The inappropriate shock induced ventricular fibrillation (vf), which the device attempted to treat with another shock but it was ineffective.A second shock was delivered which was able to convert the vf to the normal rhythm.Technical services suggested potential reprogramming parameters and additionally stated that the s-icd electrode position was suboptimal and could be a contributing factor to the low r-wave sensing.The patient presented to a follow up appointment and the physician performed isometric testing which showed low level noise.Due to patient history, the physician elected to reprogram the device and continue with close monitoring to avoid a surgical resolution.At this time, the device remains implanted and the patient was stable with no additional adverse consequences.

• 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: 9591881
• MDR Text Key: 175091797
• Report Number: 2124215-2019-28239
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526584404
• UDI-Public: 00802526584404
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P110042/S058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/04/2020
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 231433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 56 YR