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

Model Number 3501

Device Problems Failure to Sense (1559); Defective Device (2588)

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

Event Date 08/30/2022

Event Type  Injury  

Event Description

It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) electrode integrity was suspected to be compromised.Device data was sent to technical services (ts) for review.Ts confirmed that the alternate vector showed a completely flat signal with primary and secondary vectors showing a very similar signal.Ts then provided further troubleshooting options, however recommended replacement.This electrode was subsequently explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

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 326mm from the terminal pin, in the notch area of the sensing electrode.The insulation in this area also exhibited fracture damage through to the sensing cable and high voltage cable.Based on the analysis results, the fracture characteristics are non-specific at the fracture site.In december 2020, boston scientific issued an advisory notification 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

It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) electrode integrity was suspected to be compromised.Device data was sent to technical services (ts) for review.Ts confirmed that the alternate vector showed a completely flat signal with primary and secondary vectors showing a very similar signal.Ts then provided further troubleshooting options, however recommended replacement.This electrode was subsequently explanted and replaced.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; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15394696
• MDR Text Key: 299611155
• Report Number: 2124215-2022-35202
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526599200
• UDI-Public: 00802526599200
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P110042/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

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: 10/22/2021
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 168072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2022
• Initial Date FDA Received: 09/09/2022
• Supplement Dates Manufacturer Received: 10/28/2022
• Supplement Dates FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2019
• 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): Required Intervention; Hospitalization