MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION THE Q-TRAK SUBCUTANEOUS ELECTRODE; IMPLANTABLE LEAD

Model Number 3010

Device Problems Failure to Convert Rhythm (1540); Defibrillation/Stimulation Problem (1573); Under-Sensing (1661)

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

Event Date 05/02/2023

Event Type  Injury  

Event Description

It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) delivered a shock which converted the ventricular tachycardia (vt) over to ventricular fibrillation (vf).Two more shocks were delivered and converted the vf back to sinus rhythm with the third shock.Data was provided for review, boston scientific technical services confirmed the accelerated rhythm and noted that the third shock successfully terminated the rhythm.There could be multiple root causes of these occurring including inappropriate vector selection, sensing issues, and inappropriate programming.Device optimization programming suggestions were provided.No additional adverse patient effects were reported.This device and electrode remain in-service.

Event Description

It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) delivered a shock which converted the ventricular tachycardia (vt) over to ventricular fibrillation (vf).Two more shocks were delivered and converted the vf back to sinus rhythm with the third shock.Data was provided for review, boston scientific technical services confirmed the accelerated rhythm and noted that the third shock successfully terminated the rhythm.There could be multiple root causes of these occurring including inappropriate vector selection, sensing issues, and inappropriate programming.Device optimization programming suggestions were provided.No additional adverse patient effects were reported.This device and electrode remain in-service.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Please refer to b5 describe event or problem for more information regarding the specific circumstances of this event.

Event Description

It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) delivered a shock which converted the ventricular tachycardia (vt) over to ventricular fibrillation (vf), which got initially under-sensed.Two more shocks were delivered and converted the vf back to sinus rhythm with the third shock.Data was provided for review, boston scientific technical services confirmed the accelerated rhythm and noted that the third shock successfully terminated the rhythm.There could be multiple root causes of these occurring including inappropriate vector selection, sensing issues, and inappropriate programming.Device optimization programming suggestions were provided.No additional adverse patient effects were reported.This device and electrode remain in-service.

• Brand Name: THE Q-TRAK SUBCUTANEOUS ELECTRODE
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16996174
• MDR Text Key: 315877198
• Report Number: 2124215-2023-26053
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110042/S000
• 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,Followup
• Report Date: 09/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2016
• Device Model Number: 3010
• Device Catalogue Number: 3010
• Device Lot Number: A112799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other