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

Model Number 3501

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

Patient Problems Syncope (1610); Dizziness (2194); Electric Shock (2554)

Event Date 11/05/2020

Event Type  Injury  

Event Description

It was reported that this electrode and subcutaneous implantable cardioverter defibrillator (s-icd) exhibited oversensing of noise three hours post implant.Three inappropriate shocks were delivered in two separate episodes as a result.Review of the stored episode noted the electrogram (egm) signal became very small and then a wandering baseline was noted.The noise was able to be reproduced by tapping on the sternal incision and was felt to be related to air entrapment.The primary sensing vector was reprogrammed, the device was programmed off and the physician monitored the patient in the hospital overnight.No further noise was observed the following day.The air was felt to have dissipated and the patient was discharged from the hospital.No additional adverse patient effects were reported.This product remains in service.

Event Description

It was reported that the patient received additional shock therapy eight days later.The patient experienced dizziness and syncope prior to shock therapy.Interrogation of the s-icd with a programmer noted no stored treated or untreated episodes.It was noted that the patient thought the shock therapy was inappropriate and placed a magnet over the device following shock delivery.Technical services (ts) discussed the device needs about one minute post episode end to store the full data.If a magnet was placed before that time, the episode data is discarded.It was unable to be determined if therapy was appropriate or inappropriate.Monitoring will be continued.

• Brand Name: EMBLEM S-ICD
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11181677
• MDR Text Key: 227194397
• Report Number: 2124215-2020-24973
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526599200
• UDI-Public: 00802526599200
• Combination Product (y/n): N
• PMA/PMN Number: P110042/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/16/2021

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: 08/26/2022
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 183780
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 11/13/2020
• Supplement Dates FDA Received: 01/16/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR