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

Model Number	1010
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the setscrews on this subcutaneous implantable cardioverter defibrillator (s-icd) were stuck during an explant procedure for normal battery depletion.Boston scientific technical services (ts) was contacted, and ts provided possible solutions.They tried different torque wrenches, heparinized saline turning clockwise and then counterclockwise, but the setscrews remained stuck.They were eventually able to get the setscrew loose.The s-icd was successfully explanted and replaced.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; 4100 hamline ave n; st paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16404186
• Report Number: 2124215-2023-07653
• Device Sequence Number: 5742920
• Product Code: LWS
• UDI-Device Identifier: 00802526521300
• UDI-Public: 00802526521300
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2023

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: 11/04/2014
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A007195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 02/20/2023
• 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
• Patient Age: 52 YR
• Patient Sex: Male