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 Select Signal (1582); Device Displays Incorrect Message (2591); Device Sensing Problem (2917)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 07/09/2019

Event Type  Injury  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.Review of device data noted high out of range lead impedance measurements during the implant time.A batter depletion error was also noted.There were extended magnet applications that caused this error to be exhibited.The device was put through and passed the returned products test.This involves a series of automated diagnostic testing that verifies the performance of pacing, sensing, shocking and recording functions of the device commensurate with battery voltage.

Event Description

It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) exhibited a battery depletion (bd) error.Engineering confirmed the bd error was due to excessive magnet application and can be disregarded.Oversensing of noise and low morphology was also observed with the s-icd.The patient later received an inappropriate shock.Surgical intervention was performed and the s-icd was explanted and replaced.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: 9623725
• MDR Text Key: 176244889
• Report Number: 2124215-2019-28473
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526544101
• UDI-Public: 00802526544101
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/23/2020

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: 02/27/2021
• Device Model Number: A209
• Device Catalogue Number: A209
• Device Lot Number: 243160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 01/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention