MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 3501

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Inaccurate Synchronization (1609)

Patient Problems Ventricular Fibrillation (2130); Electric Shock (2554)

Event Date 02/19/2023

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 had received 18 shocks approximately 2 months ago in which this patient presented to the hospital afterwards.It was determined this patient experienced supraventricular tachycardia (svt) and medication was started.Upon review, most episodes were due to svt however the second shock induced this patient into ventricular fibrillation (vf) and the third shock successfully converted the rhythm.This electrode remains in service.No adverse patient effects were reported.

Manufacturer Narrative

Correction to device coding to include inappropriate shock, patient coding to include electric shock, and impact coding to included inadequate/inappropriate treatment or diagnostic exposure, per medical review.

Event Description

It was reported that this patient with this electrode had received 18 shocks approximately 2 months ago in which this patient presented to the hospital afterwards.It was determined this patient experienced supraventricular tachycardia (svt) and medication was started.Upon review, most episodes were due to svt however the second shock induced this patient into ventricular fibrillation (vf) and the third shock successfully converted the rhythm.This electrode remains in service.No adverse patient effects were reported.

• Brand Name: EMBLEM S-ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 16691565
• MDR Text Key: 312801455
• Report Number: 2124215-2023-16214
• 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,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• 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: 231285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• 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): Life Threatening; Hospitalization
• Patient Age: 32 YR
• Patient Sex: Male