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

Model Number 3401

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Bruise/Contusion (1754); Swelling (2091)

Event Date 11/04/2015

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that the superior tip of the electrode was protruding and irritating the patient's skin and caused bruising and swelling to occur.A revision procedure was performed where the electrode was successfully repositioned.No additional adverse patient effects were reported.

Manufacturer Narrative

This report is being filed to correct the event date.

Event Description

This report is being filed to correct the event date.

• Brand Name: EMBLEM S-ICD
• Type of Device: IMPLANTABLE ELECTRODE
• Manufacturer (Section D): OSCOR INC; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer (Section G): OSCOR, INCORPORATED
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 7665378
• MDR Text Key: 113277659
• Report Number: 2124215-2018-12144
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526575600
• UDI-Public: 00802526575600
• 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: study
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2017
• Device Model Number: 3401
• Device Catalogue Number: 3401
• Device Lot Number: A122718
• Other Device ID Number: EMBLEM Q-TRAK SQ ELECTRODE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/01/2018
• 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
• Treatment: 3401; A209
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 77