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

Model Number 3501

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Pain (1994)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

This product has not been returned; therefore, a technical analysis cannot be conducted.Without a returned product it is not possible to definitively confirm how this product may have contributed to the complaint incident.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

It was reported that following an uncomplicated system implant in a intermuscular position and a two incision technique, the patient reported intense pain following awakening from the general anesthesia, it was further reported that conversion testing had been completed and was successful, as part of the system implant testing.The pain was most intense on the left side and the patients breathing was reported as quite shallow.A ct-scan had been performed on the evening of the procedure, revealing a complication with the lead tunneling at the location where the electrode enters the thorax cavity between ribs vi & vii, and then returns to the subcutaneous space between ribs v & vi however, no pneumothorax nor hemothorax, was identified.It was suspected the pain was due to the electrode rubbing on the pleura and a revision planned and executed two days later.The electrode was cut at the location under the suture sleeve and pulled out toward the pocket.A new electrode of same model, was implanted without complication and a three incision technique performed.Following conclusion of the second implant, the patient confirmed the pain was no longer present.No return of product is expected and no further complications 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; RQ 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 11228096
• MDR Text Key: 228611464
• Report Number: 2124215-2020-29002
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P110042/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/04/2022
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 184574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 32 YR