MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SQ-RX PULSE GENERATOR; SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD)

Model Number	1010
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	03/26/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough analysis was performed.Analysis of the device memory confirmed that therapy was available at explant.The device was then subjected to returned product testing and passed, verifying the performance of sensing and shocking functions, as well as impedance testing.High powered visual inspection of the lead barrel and header of the device noted the setscrew was stuck in the upward position.It was concluded that the damage to the device was induced during procedure.
Event or Problem Description
Boston scientific received information that the patient implanted with this subcutaneous implantable cardioverter defibrillator (s-icd) system underwent a revision procedure due to a dislodged electrode which was identified at a routine follow-up from a chest x-ray.The x-ray was taken due to the patient being hospitalized recently for respiratory reasons.During the electrode revision procedure, when the physician reconnected the electrode to the device, the setscrew was stuck in the up position and would not tighten down on the electrode.The device was explanted and returned.No adverse patient effects were reported.
Additional Manufacturer Narrative
The clinical observations were confirmed through laboratory analysis as the setscrew was stuck in the up position 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 the patient implanted with this subcutaneous implantable cardioverter defibrillator (s-icd) system underwent a revision procedure due to a dislodged electrode which was identified at a routine follow-up from a chest x-ray.The x-ray was taken due to the patient being hospitalized recently for respiratory reasons.During the electrode revision procedure, when the physician reconnected the electrode to the device, the setscrew was stuck in the up position and would not tighten down on the electrode.The device was explanted and returned.No additional adverse patient effects were reported.

• Brand Name: SQ-RX PULSE GENERATOR
• Common Device Name: SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD)
• 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 degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16513362
• Report Number: 2124215-2023-11135
• Device Sequence Number: 20424734
• 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: 2012
• Device Explanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/24/2013
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A003942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2015
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 07/04/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2012
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female