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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.Visual inspection identified tool marks and scratches on the device casing.High powered microscopic visual inspection of the lead barrel and header of the device noted slight body fluid contamination.The seal plug was missing from the device and the set screw was not stuck when received.The set screw was found to move fully and freely in both directions.The hex hole in the set screw was slightly rounded out at the top, indicating a torque wrench was not fully seated into the hex hole of the set screw prior to turning it.A review of device memory revealed no functional irregularities.There were no battery fault codes or battery usage faults.The battery status at explant was elective replacement indicator (eri).The device passed longevity calculations and was exhibiting normal battery depletion.The device was put through automated therapy verification testing which confirmed proper operation of the pacing, sensing, and shocking functions of the device, as well as lead impedance and telemetry testing.It was concluded that the damage to the setscrew was induced at the time of the procedure.
Event or Problem Description
Boston scientific received information that this patient was presented back to the electrophysiology (ep) laboratory for a scheduled replacement of this chronic subcutaneous implantable cardioverter defibrillator (s-icd) due to normal battery depletion.The physician experienced some difficulties with retraction of the set screw.Eventually, the set screw was retracted and the terminal pin of the chronic electrode was successful removed from the devices header port.The s-icd was received at boston scientific's return products department.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.Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.Visual inspection identified tool marks and scratches on the device casing.High powered microscopic visual inspection of the lead barrel and header of the device noted slight body fluid contamination.The seal plug was missing from the device and the set screw was not stuck when received.The set screw was found to move fully and freely in both directions.The hex hole in the set screw was slightly rounded out at the top, indicating a torque wrench was not fully seated into the hex hole of the set screw prior to turning it.A review of device memory revealed no functional irregularities.There were no battery fault codes or battery usage faults.The battery status at explant was elective replacement indicator (eri).The device passed longevity calculations and was exhibiting normal battery depletion.The device was put through automated therapy verification testing which confirmed proper operation of the pacing, sensing, and shocking functions of the device, as well as lead impedance and telemetry testing.It was concluded that the damage to the setscrew was induced at the time of the procedure.
Event or Problem Description
It was reported that this patient was presented back to the electrophysiology (ep) laboratory for a scheduled replacement of this chronic subcutaneous implantable cardioverter defibrillator (s-icd) due to normal battery depletion.The physician experienced some difficulties with retraction of the set screw.Eventually, the set screw was retracted and the terminal pin of the chronic electrode was successful removed from the device's header port.The s-icd was received at boston scientific's return products department.No 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 ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16515396
• Report Number: 2124215-2023-11181
• Device Sequence Number: 14994652
• 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: 2012
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2023

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: 08/25/2013
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A003696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2012
• 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
• Patient Age: 85 YR
• Patient Sex: Male