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

Model Number A209

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581); Device Sensing Problem (2917); Material Integrity Problem (2978)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 03/18/2024

Event Type  Injury  

Event Description

It was reported that the patient with this subcutaneous implantable cardioverter defibrillator (s-icd) had received an inappropriate shock.Review of episode noted oversensing of sense b node noise and low amplitude morphology measurements.X-rays taken showed adequate placement of the system, however a revision procedure is still being discussed.The s-icd remains in service and there were no adverse patient effects reported.

Event Description

It was reported that the patient with this subcutaneous implantable cardioverter defibrillator (s-icd) had received an inappropriate shock.Review of episode noted oversensing of sense b node noise and low amplitude morphology measurements.X-rays taken showed adequate placement of the system; however, a revision procedure was still being discussed.Additional information provided from the field indicated surgical intervention was later performed and the s-icd was explanted and replaced.An issue with the header was suspected by the physician.No additional adverse patient effects were reported.

• Brand Name: EMBLEM 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: 18979609
• MDR Text Key: 338614401
• Report Number: 2124215-2024-18195
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110042/S043
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/28/2022
• Device Model Number: A209
• Device Catalogue Number: A209
• Device Lot Number: 134928
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization