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

Model Number 3501

Device Problems Signal Artifact/Noise (1036); Failure to Read Input Signal (1581); Low impedance (2285)

Patient Problems Twiddlers Syndrome (4563); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2023

Event Type  Injury  

Event Description

It was reported that the smartpass feature had programmed itself off due to a long pause in the patient's intrinsic rhythm.There was some myopotential noise on the electrograms.The patient's intrinsic amplitude reading was very low.Also, the shock impedance was low but within normal limits.Technical services discussed options.An x-ray was done to check the system position.The x-ray confirmed the electrode was completely pulled back into the device pocket.The system was explanted and replaced with a transvenous system.There were no additional adverse patient effects.

Manufacturer Narrative

This electrode was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.Resistance testing found the electrode was not electrically continuous.An x-ray shows the sense a and high voltage cables have fractured filars in and around the area approximately 16mm from the terminal pin.The sense a cable and a high voltage cable are fractured in and around the area approximately 16mm from the terminal pin.The fracture characteristics appeared consistent with cyclic fatigue.The fractures resulted in the observed noise, sensing, and impedance codes.

Event Description

This supplemental report is being filed to provide additional information regarding product analysis.It was reported that the smartpass feature had programmed itself off due to a long pause in the patient's intrinsic rhythm.There was some myopotential noise on the electrograms.The patient's intrinsic amplitude reading was very low.Also, the shock impedance was low but within normal limits.Technical services discussed options.An x-ray was done to check the system position.The x-ray confirmed the electrode was completely pulled back into the device pocket.The system was explanted and replaced with a transvenous system.There were no additional adverse patient effects.

Event Description

This supplemental report is being filed to correct information in the "h" tab.The electrode is not part of the field action/advisory as it was manufactured after the commencement date of the removal.It was reported that the smartpass feature had programmed itself off due to a long pause in the patient's intrinsic rhythm.There was some myopotential noise on the electrograms.The patient's intrinsic amplitude reading was very low.Also, the shock impedance was low but within normal limits.Technical services discussed options.An x-ray was done to check the system position.The x-ray confirmed the electrode was completely pulled back into the device pocket.The system was explanted and replaced with a transvenous system.There were no additional adverse patient effects.

Manufacturer Narrative

Correction: the electrode is not part of the field action/advisory capa-00005954 emblem 3501 electrode proximal fractures as it was manufactured after the commencement date of the removal.While the electrode did exhibit fracture, it was not the type of fracture addressed in the advisory capa-00005954 emblem 3501 electrode proximal fractures.This electrode was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.Resistance testing found the electrode was not electrically continuous.An x-ray shows the sense a and high voltage cables have fractured filars in and around the area approximately 16mm from the terminal pin.The fracture characteristics appeared consistent with cyclic fatigue.The fractures resulted in the observed noise, sensing, and impedance codes.

• 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; 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: 16437159
• MDR Text Key: 310167863
• Report Number: 2124215-2023-08739
• 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: Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2023

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 Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 232452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2023
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 07/20/2023; 12/11/2023
• Supplement Dates FDA Received: 07/25/2023; 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0879-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 52 YR
• Patient Sex: Female