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

Model Number 3501

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Material Integrity Problem (2978)

Patient Problem Electric Shock (2554)

Event Date 10/31/2023

Event Type  Injury  

Event Description

It was reported that following an unrelated traffic accident, this patient received three inappropriate shocks due to over-sensed artifacts from this subcutaneous implantable cardiac defibrillator (s-icd) system.It was suspected that the s-icd electrode had suffered physical damage due to the traffic accident, and this resulted in the over-sensed noise and inappropriate therapy.The patient was hospitalized and provocative maneuvers were performed and the noise was reproducible.X-ray imaging was also performed, but no clear evidence of damage was found.This information was provided to boston scientific technical services (ts) and a system revision procedure was strongly recommended.Shock therapy was disabled via programming to prevent further inappropriate therapy.The physician subsequently explanted and replaced the s-icd system to resolve the event and the patient was stable.The explanted s-icd system is expected to be returned for analysis, but has not yet been received.

Manufacturer Narrative

This electrode was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.Visual examination revealed no abnormalities near the proximal electrode cable.However, a tear in the terminal end and suture sleeve of the electrode was noted.Resistance testing found the electrode was not electrically continuous.An x-ray of the electrode confirmed the inner conductor coil was fractured approximately 315 mm on the distal electrode cable.Analysis has determined that in certain tight bend conditions of the s-icd lead, highly localized stresses are created that, when exposed to repeated movement, may lead to a fatigue fracture.

Event Description

It was reported that following an unrelated traffic accident, this patient received three inappropriate shocks due to over-sensed artifacts from this subcutaneous implantable cardiac defibrillator (s-icd) system.It was suspected that the s-icd electrode had suffered physical damage due to the traffic accident, and this resulted in the over-sensed noise and inappropriate therapy.The patient was hospitalized and provocative maneuvers were performed and the noise was reproducible.X-ray imaging was also performed, but no clear evidence of damage was found.This information was provided to boston scientific technical services (ts) and a system revision procedure was strongly recommended.Shock therapy was disabled via programming to prevent further inappropriate therapy.The physician subsequently explanted and replaced the s-icd system to resolve the event and the patient was stable.The explanted s-icd system has been received for analysis.

• Brand Name: EMBLEM S-ICD ELECTRODE
• 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: 18089111
• MDR Text Key: 327585827
• Report Number: 2124215-2023-62687
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110042/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

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 Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 225258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 02/19/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization