MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE LEAD

Model Number 3501

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Failure to Sense (1559); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 01/09/2021

Event Type  Injury  

Event Description

It was reported that the patient received two inappropriate shocks due to oversensing of noise with decreased sensing.The field representative noted that the sensing appeared flat.The patient has no sternal wires and good measurements.Boston scientific technical services (ts) was contacted and discussed possible causes including air entrapment.Ts further suggested an x-ray.The physician agreed that this could be related to air entrapment and had the subcutaneous implantable cardioverter defibrillator (s-icd) programmed off for three weeks.The patient was brought in three weeks later where the set up was re-initiated and no noise was observed.Sensing was also good.The s-icd was turned back on and no additional adverse patient effects were reported.

• Brand Name: EMBLEM S-ICD
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 11717683
• MDR Text Key: 247222771
• Report Number: 2124215-2021-04718
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526599200
• UDI-Public: 00802526599200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110042/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/11/2022
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 179769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2021
• Initial Date FDA Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR