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

Model Number	1010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) was part of a system revision due to suspected nickel allergy.There were no additional adverse patient effects reported.This s-icd was explanted.
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) was part of a system revision due to suspected nickel allergy.There were no additional adverse patient effects reported.This s-icd was explanted.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, additional information from product investigation indicates that the allegation against the device was not confirmed.This device was analyzed, passed all the baseline tests and exhibited normal device functions.This supplemental is being filed to capture the investigation results.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SQ-RX PULSE GENERATOR
• Common Device Name: 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; cashel road; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17599387
• Report Number: 2124215-2023-45282
• Device Sequence Number: 15346006
• Product Code: LWS
• UDI-Device Identifier: 00802526562808
• UDI-Public: 00802526562808
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/17/2015
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A015991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female