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

Model Number 3501

Device Problem Defective Device (2588)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 03/16/2023

Event Type  Injury  

Event Description

It was reported that this electrode was part of a subcutaneous implantable cardioverter defibrillator (s-icd) system explant due to suspected infection.However, it has since been discovered that the patient is allergic to cobalt which is an element present in the electrode shocking coil, sense b and suture tip.It is now assumed that the suspected infection that prompted the system explant was likely actually an allergic reaction.No additional adverse patient effects were reported.Product return is not expected.Of note, this event was reported to the field long after explant.Therefore, no further information has been provided or is known.

Event Description

It was reported that this electrode was part of a subcutaneous implantable cardioverter defibrillator (s-icd) system explant due to suspected infection.However, it has since been discovered that the patient is allergic to cobalt which is an element present in the electrode shocking coil, sense b and suture tip.It is now assumed that the suspected infection that prompted the system explant was likely actually an allergic reaction.No additional adverse patient effects were reported.Product return is not expected.Of note, this event was reported to the field long after explant.Therefore, no further information has been provided or is known.Should additional information be received in the future, an updated report will be issued.

Manufacturer Narrative

Product return is not expected.Therefore, technical analysis cannot be conducted.At this point, it can be concluded that patient condition most likely contributed to the event.Should additional follow-up information be provided in the future, a supplemental report will be issued.

• 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: 16601835
• MDR Text Key: 311921925
• Report Number: 2124215-2023-13820
• Device Sequence Number: 1
• Product Code: LWS
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization