MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SQ-RX PULSE GENERATOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	1010
Medical Device Problem Codes	Premature Discharge of Battery (1057); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	12/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) delivered one shock as inappropriate therapy due to a suspected supraventricular tachycardia (svt).Technical services (ts) discussed the device programmed settings and available programming options.Ts also informed the calling field representative the device had reached elective replacement indicator (eri) and was under an advisory notice for it to be replaced within 20 days of it reaching eri, so it recommended for the device to be replaced.The field representative indicated they would discuss it with the patients physician.The device remains in service and there is no indication a replacement procedure has taken place.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) delivered one shock as inappropriate therapy due to a suspected supraventricular tachycardia (svt).Technical services (ts) discussed the device programmed settings and available programming options.Ts also informed the calling field representative the device had reached elective replacement indicator (eri) and was under an advisory notice for it to be replaced within 20 days of it reaching eri, so it recommended for the device to be replaced.The field representative indicated they would discuss it with the patients physician.The device remains in service and there is no indication a replacement procedure has taken place.No additional adverse patient effects were reported.The device has been explanted and replaced.
Additional Manufacturer Narrative
Amendment corrected fields: h6 impact codes.
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) delivered one shock as inappropriate therapy due to a suspected supraventricular tachycardia (svt).Technical services (ts) discussed the device programmed settings and available programming options.Ts also informed the calling field representative the device had reached elective replacement indicator (eri) and was under an advisory notice for it to be replaced within 20 days of it reaching eri, so it recommended for the device to be replaced.The field representative indicated they would discuss it with the patients physician.The device remains in service and there is no indication a replacement procedure has taken place.No additional adverse patient effects were reported.The device has been explanted and replaced.

• Brand Name: SQ-RX PULSE GENERATOR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18597019
• Report Number: 2124215-2024-04575
• Device Sequence Number: 8033897
• Product Code: LWS
• UDI-Device Identifier: 00802526562808
• UDI-Public: 00802526562808
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P110042/S000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/22/2016
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A019549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 01/25/2024; 04/02/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 02/02/2024; 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male