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

Model Number 3501

Device Problems High impedance (1291); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2024

Event Type  Injury  

Event Description

It was reported that the patient was hearing beeping for about three weeks.An office follow-up found the electrode impedance was high and out of range.The impedance data changed abruptly from in-range to out-of-range this past january.An xray was done, and an electrode fracture was confirmed.The doctor is aware.There were no adverse patient effects.The electrode remains implanted.

Event Description

This supplemental report is being filed to provide additional information that the product has been explanted and replaced.The doctor elected to explant both the pulse generator and the electrode.Both products were successfully replaced.There were no additional adverse patient effects.It was reported that the patient was hearing beeping for about three weeks.An office follow-up found the electrode impedance was high and out of range.The impedance data changed abruptly from in-range to out-of-range this past january.An xray was done, and an electrode fracture was confirmed.The doctor is aware.There were no adverse patient effects.The electrode remains implanted.

Manufacturer Narrative

The electrode was returned severed at approximately 325mm from the terminal end.Upon receipt at our post market quality assurance laboratory, this electrode was thoroughly inspected and analyzed.Resistance testing confirmed the electrode was fractured and visual examination determined the fracture was located approximately 325mm from the terminal pin, (in the notch area adjacent to the sense b electrode).Based on the analysis results, the fracture appears to be the result of cyclic fatigue at the fracture site.In december 2020, boston scientific issued a field safety notice regarding the potential for emblem s-icd subcutaneous electrodes to exhibit a lead body fracture just distal to the proximal sense ring.This electrode is a part of the advisory population.

Event Description

This supplemental report is being filed to provide additional information regarding product analysis.This supplemental report is being filed to provide additional information that the product has been explanted and replaced.The doctor elected to explant both the pulse generator and the electrode.Both products were successfully replaced.There were no additional adverse patient effects.It was reported that the patient was hearing beeping for about three weeks.An office follow-up found the electrode impedance was high and out of range.The impedance data changed abruptly from in-range to out-of-range this past january.An xray was done, and an electrode fracture was confirmed.The doctor is aware.There were no adverse patient effects.The electrode remains implanted.

• 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: 18816952
• MDR Text Key: 337541664
• Report Number: 2124215-2024-12561
• 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: 05/08/2024

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: 01/03/2021
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 151879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 03/01/2024; 05/08/2024
• Supplement Dates FDA Received: 03/07/2024; 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2019
• 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: 51 YR
• Patient Sex: Male