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

Model Number 3501

Device Problems Signal Artifact/Noise (1036); Fracture (1260); Over-Sensing (1438); Failure to Sense (1559); Under-Sensing (1661); Connection Problem (2900); Material Integrity Problem (2978)

Patient Problems Twiddlers Syndrome (2114); No Code Available (3191)

Event Date 07/29/2020

Event Type  Injury  

Manufacturer Narrative

The product has been received for analysis.This report will be updated upon completion of analysis.(b)(4).

Event Description

It was reported that a clinician contacted boston scientific technical services (ts) for review a presenting electrogram.Ts noted possible telemetry drop out and discussed concern over possible sternal wires, under insertion, sharp bends or conductor damage.The field representative saw the patient the following day and noted that the patient's history show no indication of sternal wires.During an in office interrogation prior to having a chest x-ray noise was observed when the patient moved in his chair.There was no noise in the secondary vector but noise was seen in both primary and alternate vectors.The subcutaneous implantable cardioverter defibrillator (s-icd) was reprogrammed to secondary sensing vector.Review of the x-rays found the s-icd was in a different orientation and the electrode was tangled and kinked.Ts reviewed the x-rays and further noted there appeared to be either twiddling or migration of the s-icd via movement.Ts also observed a sharp bend in the electrode when viewing the lateral film.It was discussed that labeling states to avoid sharp bends in the electrode.Ts recommended a revision procedure to assess the system as the electrode could have conductor damage or there could be insertion issues which could lead to compromised therapy.A revision procedure was performed a couple months later due to concerns over under insertion, twiddler's syndrome and conductor damage.The s-icd and electrode were explanted and a single change transvenous implantable cardioverter defibrillator (icd) and right ventricular (rv) lead were implanted.No additional adverse patient effects were reported.

Event Description

This report is being filed to submit the analysis results.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this electrode was thoroughly inspected and analyzed.Resistance testing confirmed the electrode was fractured and visual examination determined the fracture was located just distal to the terminal pin.There was a slight twist in the electrode just distal to the terminal pin and surface abrasion above the fracture site.The field allegations of oversensing and noise were confirmed.Based on the analysis results, the fracture appears to be the result of cyclic fatigue at the fracture site.Patient code 3191 captures the reportable event of surgery.

• Brand Name: EMBLEM S-ICD
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10714238
• MDR Text Key: 212388003
• Report Number: 2124215-2020-21076
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526599200
• UDI-Public: 00802526599200
• Combination Product (y/n): N
• PMA/PMN Number: P110042/S077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2021

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: 05/10/2020
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 119586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 11/19/2020
• Supplement Dates FDA Received: 01/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR