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

Model Number 3501

Device Problems Failure to Sense (1559); Low impedance (2285); Device Dislodged or Dislocated (2923)

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

Event Date 03/05/2024

Event Type  Injury  

Event Description

It was reported that at a recent follow-up appointment the impedance of the subcutaneous implantable cardioverter defibrillator (s-icd) system was less than 30 ohms and there was a lack of sensing in the primary vector.X-ray revealed that the electrode had pulled back, resulting in sense b being in close proximity to the pocket.The patient was to be scheduled for electrode revision.No adverse patient effects were reported.

Event Description

It was reported that at a recent follow-up appointment the impedance of the subcutaneous implantable cardioverter defibrillator (s-icd) system was less than 30 ohms and there was a lack of sensing in the primary vector.X-ray revealed that the electrode had pulled back, resulting in sense b being in close proximity to the pocket.The patient underwent a complete system replacement.No additional adverse patient effects were reported.

• Brand Name: EMBLEM S-ICD
• Type of Device: IMPLANTABLE DEVICE
• 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 ; * 00646
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18870940
• MDR Text Key: 337444588
• Report Number: 2124215-2024-14377
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P110042/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 250498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2023
• 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