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

Model Number 3400

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Anxiety (2328); Electric Shock (2554)

Event Date 10/01/2020

Event Type  Injury  

Event Description

It was reported that the patient implanted with this subcutaneous implantable cardioverter defibrillator (s-icd) system received inappropriate shocks due to oversensing.Which led to the patient experiencing anxiety.A revision procedure was performed and the s-icd system was explanted.No additional adverse patient effects were reported.

• Brand Name: THE Q-TRAK SUBCUTANEOUS ELECTRODE
• Type of Device: IMPLANTABLE ELECTRODE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 229 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16565665
• MDR Text Key: 311504034
• Report Number: 2124215-2023-12786
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526563201
• UDI-Public: 00802526563201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110042/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2016
• Device Model Number: 3400
• Device Catalogue Number: 3400
• Device Lot Number: A116855
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female