MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SQ-RX PULSE GENERATOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	1010
Medical Device Problem Codes	Connection Problem (2900); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a routine device replacement procedure, the setscrew was unable to be loosened to remove the electrode from the header of this subcutaneous implantable cardioverter defibrillator (s-icd).Technical services (ts) discussed troubleshooting options.The setscrew was unable to be loosened following troubleshooting.The device header was cut, however, the electrode was difficult to push out of the header.Mineral oil was used and the electrode was successfully removed.This device was explanted and replaced.No adverse patient effects were reported.The product has been received for analysis.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed.Visual inspection identified scratches and dents on the device case.The set screw was found to be stuck in the up position and the header was broken apart from the device case.Only a small portion of the header was returned containing the set screw and terminal block.The device was unable to be subjected to automated testing due to the damage to the set screw and device header.Analysis concluded that the damage to the device was consistent with induced damage and analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.Representatives from our quality assurance, manufacturing, and design engineering groups are actively investigating this behavior.Our ongoing investigation efforts are currently focused on understanding the root cause to mitigate the potential for setscrew issues when disconnecting the electrode from these s-icds.Information gained through these efforts will be utilized to implement appropriate preventive action(s), as necessary.

• Brand Name: SQ-RX PULSE GENERATOR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 16513040
• Report Number: 2124215-2023-11130
• Device Sequence Number: 6296732
• Product Code: LWS
• UDI-Device Identifier: 00802526521300
• UDI-Public: 00802526521300
• 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: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2023

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: 04/07/2015
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A010902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2023
• Initial Report FDA Received Date: 03/09/2023
• 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: 50 YR
• Patient Sex: Male