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

Model Number	1010
Medical Device Problem Codes	Difficult to Remove (1528); Defective Device (2588); Connection Problem (2900); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The clinical observations were confirmed through laboratory analysis as the setscrew was stuck in the capture washer against the retaining washer, and the force required to loosen the setscrew was greater than the force that would be exerted by the torque wrench packaged with this device.The instructions for use (ifu) provides additional instructions on how to loosen stuck setscrews if they occur during procedures and reminds users not to back the setscrew out against the backstop.
Event or Problem Description
It was reported that during a subcutaneous implantable cardioverter defibrillator (s-icd) generator replacement procedure for normal battery depletion, a set screw got stuck and would not move.Multiple wrenches were used and were damaged in the attempts to remove the set screw.The silicone seal was removed from the s-icd and saline injected into the header.Finally, the set screw appeared to be released and the electrode came out of the port without issue.A new s-icd was successfully implanted.No adverse patient effects were reported.

• Brand Name: SQ-RX PULSE GENERATOR
• Common Device Name: IMPLANTABLE DEVICE
• 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: 17039968
• Report Number: 2124215-2023-27858
• Device Sequence Number: 6898211
• Product Code: LWS
• UDI-Device Identifier: 00802526562808
• UDI-Public: 00802526562808
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2023

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: 11/21/2015
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A014642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 06/01/2023
• 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
• Patient Age: 37 YR
• Patient Sex: Male