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

Model Number 3501

Device Problems Use of Device Problem (1670); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/20/2024

Event Type  malfunction  

Event Description

It was reported that during the patient's sternotomy procedure back in february the physician accidently transected the electrode.This resulted in therapy being programmed off.At this time, the subcutaneous implantable cardioverter defibrillator (s-icd) system remains in service.No adverse patient effects were reported.

Event Description

It was reported that during the patient's sternotomy procedure back in february the physician accidently transected the electrode.This resulted in therapy being programmed off.At this time, the subcutaneous implantable cardioverter defibrillator (s-icd) system remains in service.No adverse patient effects were reported.This supplemental report is being filed as additional information was received which reported that this subcutaneous implantable cardioverter defibrillator (s-icd) was explanted and replaced with a transvenous system.No additional adverse patient effects were reported.

• Brand Name: EMBLEM S-ICD
• Type of Device: IMPLANTABLE ELECTRODE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18980450
• MDR Text Key: 338623332
• Report Number: 2124215-2024-18233
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526599200
• UDI-Public: 00802526599200
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/23/2020
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 113259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male