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); Failure to Read Input Signal (1581); Migration (4003)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.(b)(4)d.

Event Description

It was reported that following implant of this subcutaneous implanted cardioverter defibrillator, this patient was inappropriately shocked twenty five times.Shock impedance measurements were within normal limits but varied from 70 ohms to 172 ohms.The device was in primary vector and a wandering baseline, rail-to-rail noise, flat lines and intermittent non physiologic blips were all observed in various stored episodes.It was noted that positioning looked appropriate at implant; however, the electrode migrated with the patient tissue during body movement and the device could not detect cardiac electricity.The device was programmed off and a revision procedure was performed.The physician used the three incision technique to lock the electrode in place.The patient experienced trauma due to the additional surgery.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; RQ 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 11233616
• MDR Text Key: 228836837
• Report Number: 2124215-2021-02221
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/21/2022
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 183360
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 55 YR