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

Model Number	1010
Medical Device Problem Codes	Difficult to Remove (1528); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter-defibrillator (s-icd) was being removed for normal battery depletion.During the procedure, the electrode was found to be stuck in the header.The hex wrench turned the set screw and pulled on the electrode to remove it from the header, the screw was released successfully.The electrode measurements were ok and thus, the electrode was used with the new device.There was no harm reported to the patient.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.Boston scientific determined the most probable cause of the event was related to an unintended user error.The s-icd instructions for use (ifu) cautions users against using a non-boston scientific torque wrench and over-ratcheting the wrench when loosening setscrews on our devices which could result in them becoming stuck.The ifu provides additional instructions on how to loosen stuck setscrews if they occur during procedures.However, boston scientific is currently investigating these cases of difficulty loosening stuck setscrews to determine what other factors may contribute to these events.

• Brand Name: SQ-RX PULSE GENERATOR
• Common Device Name: IMPLANTABLE ELECTRODE
• 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: 16636293
• Report Number: 2124215-2023-14709
• Device Sequence Number: 17950483
• Product Code: LWS
• UDI-Device Identifier: 00802526562808
• UDI-Public: 00802526562808
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2023

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: 06/02/2015
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A015252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 03/29/2023
• 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: 39 YR
• Patient Sex: Female