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

Model Number	1010
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) exhibited normal battery depletion.A revision procedure was performed, and the physician experienced difficulty to remove this s-icd and then was successfully replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The set screw was found to be stuck in the up position.A portion of a hex wrench was found to be broken off flush with the top of the set screw and lodged in the hex hole of the set screw.This portion of the hex wrench could not be removed from the set screw to allow further testing.Analysis of the device memory reveals no functional irregularities.No battery fault codes were noted in the device memory.No battery usage faults were noted in the device memory.Normal telemetry operations were noted during testing and detailed analysis.Memory analysis confirms proper operation of the device during the time of implant and therapy availability was not compromised.
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) exhibited normal battery depletion.A revision procedure was performed, and the physician experienced difficulty to remove this s-icd and then was successfully replaced.No additional adverse patient effects were reported.

• Brand Name: SQ-RX PULSE GENERATOR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 16827009
• Report Number: 2124215-2023-20425
• Device Sequence Number: 6850098
• Product Code: LWS
• UDI-Device Identifier: 00802526562808
• UDI-Public: 00802526562808
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P110042/S000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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,Followup
• Report Date (Section B): 12/21/2023

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: 11/18/2015
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A015976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 12/21/2023
• 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: 54 YR
• Patient Sex: Male