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

Model Number	1010
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a normal device change out procedure the setscrew on the subcutaneous implantable cardioverter defibrillator (s-icd) was unable to be loosened using a non-torquing wrench.Technical services (ts) was consulted mid case, however before any troubleshooting occurred the physician was able to loosen the setscrew.The s-icd was explanted as planned.It was noted that the s-icd was not expected to be returned for analysis as the explanting hospital kept possession of device.No adverse patient effects were reported.
Additional Manufacturer Narrative
It was noted that the s-icd was not expected to be returned for analysis as the explanting hospital kept possession of device.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.

• 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; 229 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16539819
• Report Number: 2124215-2023-12006
• Device Sequence Number: 17690611
• Product Code: LWS
• UDI-Device Identifier: 00802526521300
• UDI-Public: 00802526521300
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P110042/S000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/21/2014
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A007450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 03/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male