MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD ELECTRODE DELIVERY SYSTEM; ACCESSORY

Model Number 4712

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

Patient Problems Nausea (1970); Pain (1994); Pneumothorax (2012)

Event Date 08/30/2022

Event Type  Injury  

Event Description

It was reported that at the implant of an subcutaneous implantable cardioverter defibrillator (s-icd), defibrillation threshold (dft) testing was initially unsuccessful at 65 joules.Additional external and device shocks were delivered which were unsuccessful.A commanded 80 joule shock was delivered which successfully converted the patient.At the time of the unsuccessful dft it was suspected to be due to low ejection fraction, however in the recovery room the patient reported feeling severe pain and nausea.A chest x-ray was completed which revealed a pneumothorax.A computed tomography scan was also performed showing the electrode in the left lobe of the lung.The system was explanted and a chest tube was placed.A transvenous system was subsequently implanted.No additional adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.A pneumothorax occurred during the implant procedure and evidence suggests the tunneling tool had entered the patient's lung.Please refer to the section b5 for more information regarding the specific circumstances of this event.

Event Description

It was reported that at implant of an subcutaneous implantable cardioverter defibrillator (s-icd), defibrillation threshold (dft) testing was initially unsuccessful at 65 joules.Additional external and device shocks were delivered which were unsuccessful.A commanded 80 joule shock was delivered which successfully converted the patient.At the time of the unsuccessful dft it was suspected to be due to low ef, however in the recovery room the patient reported feeling severe pain and nausea.A chest x-ray was completed which revealed a pneumothorax.A ct scan was also performed showing the electrode in the left lobe of the lung.The system was explanted and a chest tube was placed.A transvenous system was subsequently implanted.No additional adverse patient effects were reported.

• Brand Name: EMBLEM S-ICD ELECTRODE DELIVERY SYSTEM
• Type of Device: ACCESSORY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15514145
• MDR Text Key: 300877730
• Report Number: 2124215-2022-38812
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110042/S102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 04/17/2023

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: Health Professional
• Device Model Number: 4712
• Device Catalogue Number: 4712
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 03/23/2023
• Supplement Dates FDA Received: 04/17/2023
• 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
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 68 KG