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

Model Number 3501

Device Problems Signal Artifact/Noise (1036); Unexpected Therapeutic Results (1631)

Patient Problem Fall (1848)

Event Date 04/09/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this patient with this electrode experienced ventricular tachycardia (vt) and received multiple shocks within 2 days.Technical services (ts) reviewed and noted the therapy was appropriately delivered however was delayed due to noise that was observed.This patient had fallen out of bed after one of the episodes and subsequently has been hospitalized.Ts recommended isometrics testing to look for noise with the goal of choosing a better vector.This electrode remains in service.No adverse patient effects were reported.

Manufacturer Narrative

Correction to impact coding; added f05 delay to treatment/therapy, per medical review.

Event Description

It was reported that this patient with this electrode experienced ventricular tachycardia (vt) and received multiple shocks within 2 days.Technical services (ts) reviewed and noted the therapy was appropriately delivered however was delayed due to noise that was observed.This patient had fallen out of bed after one of the episodes and subsequently has been hospitalized.Ts recommended isometrics testing to look for noise with the goal of choosing a better vector.This electrode 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: 16773779
• MDR Text Key: 313629349
• Report Number: 2124215-2023-18824
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• 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: 228981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2022
• 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: 38 YR
• Patient Sex: Male