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

Model Number	1010
Medical Device Problem Codes	Connection Problem (2900); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
It was reported that at the elective procedure to explant this subcutaneous implantable cardioverter defibrillator (s-icd), the electrode could not be removed from the device header due to a stuck setscrew.A competitive ratcheting wrench and non ratcheting wrench were both used without success.The non ratcheting wrench became bent during the efforts.The header was detached from the device and the physician was able to bore the setscrew down with a screw removal kit.The pin was finally released from the header.The electrode functioned normally and a replacement s-icd was implanted without further incident.No adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt in the post market quality assurance laboratory, visual inspection confirmed the device header had been removed from the case and the seal was missing from the setscrew.Further analysis of this product could not be performed due to the device damage.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
It was reported that at the elective procedure to explant this subcutaneous implantable cardioverter defibrillator (s-icd), the electrode could not be removed from the device header due to a stuck setscrew.A competitive ratcheting wrench and non ratcheting wrench were both used without success.The non ratcheting wrench became bent during the efforts.The header was detached from the device and the physician was able to bore the setscrew down with a screw removal kit.The pin was finally released from the header.The electrode functioned normally and a replacement s-icd was implanted without further incident.No adverse patient effects were reported.

• 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: 14691498
• Report Number: 2124215-2022-21370
• Device Sequence Number: 20165260
• Product Code: LWS
• UDI-Device Identifier: 00802526521300
• UDI-Public: 00802526521300
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2023

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: Health Professional
• Device Expiration Date: 03/07/2015
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A010237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female