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

Model Number 3501

Device Problem Device Sensing Problem (2917)

Patient Problems Presyncope (4410); Syncope/Fainting (4411)

Event Date 01/24/2022

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 and subcutaneous implantable cardioverter defibrillator (s-icd) underwent a premature ventricular contraction (pvc) ablation procedure in which this s-icd therapy was to be turned off for.Automatic setup was run post procedure when attempting to turn therapy back on, and all sensing vectors failed.Evaluation in several patient positions were attempted which were unsuccessful.Therapy was then going to be turned on without smart pass and be followed up in the future.This patient noted this had occurred since the implant procedure.Then, this patient presented to the emergency room with pre syncope and syncope.A surface electrocardiogram (ecg) revealed that this patient was having intermittent heart block, likely the result of the pvc ablation earlier in the week.The on call electrophysiologist decided to implant a cardiac resynchronization therapy defibrillator (crt-d).The s-icd system therapy was turned off as there was still no sensing.This patient will be evaluated at a later time as to if this s-icd system will remain implanted with therapy off or explanted.This electrode remains implanted currently.No adverse patient effects were reported.

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 and subcutaneous implantable cardioverter defibrillator (s-icd) underwent a premature ventricular contraction (pvc) ablation procedure in which this s-icd therapy was to be turned off for.Automatic setup was run post procedure when attempting to turn therapy back on, and all sensing vectors failed.Evaluation in several patient positions were attempted which were unsuccessful.Therapy was then going to be turned on without smart pass and be followed up in the future.This patient noted this had occurred since the implant procedure.Then, this patient presented to the emergency room with pre syncope and syncope.A surface electrocardiogram (ecg) revealed that this patient was having intermittent heart block, likely the result of the pvc ablation earlier in the week.The on call electrophysiologist decided to implant a cardiac resynchronization therapy defibrillator (crt-d).The s-icd system therapy was turned off as there was still no sensing.This patient will be evaluated at a later time as to if this s-icd system will remain implanted with therapy off or explanted.This electrode remains implanted currently.No adverse patient effects were reported.Additional information was received that this electrode was explanted.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned electrode was thoroughly inspected and analyzed.Resistance tests were completed to assess electrical performance and inner insulation integrity.Measurements throughout these tests were within normal limits.Laboratory analysis did not identify any electrode characteristics that would have caused or contributed to the reported clinical observations.

Event Description

It was reported that this patient with this electrode and subcutaneous implantable cardioverter defibrillator (s-icd) underwent a premature ventricular contraction (pvc) ablation procedure in which this s-icd therapy was to be turned off for.Automatic setup was run post procedure when attempting to turn therapy back on, and all sensing vectors failed.Evaluation in several patient positions were attempted which were unsuccessful.Therapy was then going to be turned on without smart pass and be followed up in the future.This patient noted this had occurred since the implant procedure.Then, this patient presented to the emergency room with pre syncope and syncope.A surface electrocardiogram (ecg) revealed that this patient was having intermittent heart block, likely the result of the pvc ablation earlier in the week.The on call electrophysiologist decided to implant a cardiac resynchronization therapy defibrillator (crt-d).The s-icd system therapy was turned off as there was still no sensing.This patient will be evaluated at a later time as to if this s-icd system will remain implanted with therapy off or explanted.This electrode remains implanted currently.No adverse patient effects were reported.Additional information was received that this electrode was explanted.No additional 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: 16751969
• MDR Text Key: 313416549
• Report Number: 2124215-2023-17876
• 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,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/20/2023
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 205330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 04/17/2023
• Supplement Dates Manufacturer Received: 05/10/2023; 07/07/2023
• Supplement Dates FDA Received: 05/16/2023; 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2021
• 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; Other
• Patient Age: 64 YR
• Patient Sex: Male