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

Model Number 3501

Device Problems Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

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

Event Date 03/14/2023

Event Type  Injury  

Event Description

It was reported that the electrode of this implantable lead was dislocated.The lead remains in service.No adverse patient effects were reported.

Manufacturer Narrative

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

Manufacturer Narrative

This report is being filed to correct the following fields from the previously submitted report: d6a implant date to (b)(6) 2021.

Event Description

This supplemental report is being filed to provide additional information that the electrode had moved.An x-ray was done, and the doctor could see the electrode had moved downward and the pulse generator has rotated.The sensing vector has now been reprogrammed from primary to secondary.The doctor will do defibrillation threshold testing, and possibly re-implant the system later on.There were no adverse patient effects.The system remains implanted.It was reported that the electrode of this implantable lead was dislocated.The lead remains in service.No adverse patient effects were reported.

Event Description

This supplemental report is being filed to provide additional information that the electrode had moved.An x-ray was done, and the doctor could see the electrode had moved downward and the pulse generator has rotated.The sensing vector has now been reprogrammed from primary to secondary.The doctor will do defibrillation threshold testing, and possibly re-implant the system later on.There were no adverse patient effects.The system remains implanted.It was reported that the electrode of this implantable lead was dislocated.The lead remains in service.No adverse patient effects were reported.

Manufacturer Narrative

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

Event Description

This supplemental report is being filed to provide additional information that the electrode was successfully repositioned.During the procedure, it was discovered that the suture thread holding the sleeve in place had broken.There were no additional adverse patient effects.The electrode remains implanted.This supplemental report is being filed to provide additional information that the electrode had moved.An x-ray was done, and the doctor could see the electrode had moved downward and the pulse generator has rotated.The sensing vector has now been reprogrammed from primary to secondary.The doctor will do defibrillation threshold testing, and possibly re-implant the system later on.There were no adverse patient effects.The system remains implanted.It was reported that the electrode of this implantable lead was dislocated.The lead remains in service.No adverse patient effects 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; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16677478
• MDR Text Key: 312645618
• Report Number: 2124215-2023-15796
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110042/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/27/2022
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 160526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2020
• 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
• Patient Age: 25 YR
• Patient Sex: Male