MAUDE Adverse Event Report: OSCOR INC EMBLEM S-ICD; IMPLANTABLE LEAD

Model Number 3401

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930)

Event Date 02/24/2023

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this implantable lead was part of a system revision due to infection.There were no additional adverse patient effects reported.The implantable lead was surgically abandoned.

Manufacturer Narrative

This supplemental report was created to update h6: patient codes with purulent drainage and d6b: explant date.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this implantable lead was part of a system revision due to infection.There were no additional adverse patient effects reported.The implantable lead was explanted.

Event Description

It was reported that this implantable lead was part of a system revision due to infection.There were no additional adverse patient effects reported.The implantable lead was explanted.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, additional information from product investigation indicates that the allegation against the lead was not confirmed.This lead was analyzed, passed all the baseline tests and exhibited normal lead functions.This supplemental is being filed to capture d9: returned to manufacturer date and investigation results.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EMBLEM S-ICD
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): OSCOR INC; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16480867
• MDR Text Key: 310636324
• Report Number: 2124215-2023-10144
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526585968
• UDI-Public: 00802526585968
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110042/S043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2023

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2018
• Device Model Number: 3401
• Device Catalogue Number: 3401
• Device Lot Number: A140076
• 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: 03/03/2023
• Supplement Dates Manufacturer Received: 03/30/2023; 07/19/2023
• Supplement Dates FDA Received: 04/05/2023; 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 64 YR
• Patient Sex: Male