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

Model Number 3501

Device Problems Failure to Sense (1559); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that one day post implant, this electrode and subcutaneous implantable cardioverter defibrillator (s-icd) experienced a lack of sensing, low r wave amplitude and a flatline on the subcutaneous electrogram (egm) strip, resulting in untreated episodes and an inappropriate shock.The smart pass feature of the s-icd was disabled.The field representative noted that there was no saline flush during the procedure.Technical services reviewed and noted this was likely air bubbles or a possible insertion issue and suggested x rays to confirm insertion.Additional information is being requested from the field.This electrode remains in service.No adverse patient effects were reported.

Event Description

It was reported that one day post implant, this electrode and subcutaneous implantable cardioverter defibrillator (s-icd) experienced a lack of sensing, low r wave amplitude and a flatline on the subcutaneous electrogram (egm) strip, resulting in untreated episodes and an inappropriate shock.The smart pass feature of the s-icd was disabled.The field representative noted that there was no saline flush during the procedure.Technical services reviewed and noted this was likely air bubbles or a possible insertion issue and suggested x rays to confirm insertion.Additional information is being requested from the field.This electrode remains in service.No adverse patient effects were reported.Additional information was received that it was unknown if x rays were performed.Device testing showed no further sensing issues.No further action or intervention is planned to my knowledge and no further patient complications.

Manufacturer Narrative

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

• 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: 18848801
• MDR Text Key: 337527479
• Report Number: 2124215-2024-13789
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 250710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• 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 Age: 50 YR
• Patient Sex: Male