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	08/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a change out procedure the physician was unable to loosen the setscrew on the subcutaneous implantable cardioverter defibrillator (s-icd) even after trying multiple wrenches.It was noted the non-torque wrench ratched but did not turn the setscrew.The physician was concerned that the threads were jammed.After multiple attempts the physician put mineral oil in and waited five minutes.Then they were able to successfully retract the setscrew and remove the terminal pin.There was no damage to the terminal pin of the electrode, and it had good sensing measurements and was able to remain implanted with the new device.It was noted the header of the explanted s-icd was damaged.No adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory visual inspection revealed the medical adhesive that filled the spot weld wire cavity of the high voltage setscrew connector block had been cut away and the spot weld wire had been broken away from its spot weld and cut.A portion of the wire was missing, and the remaining portion of the wire was no longer connected.During testing the setscrew operated normally in both directions.It was noted that the feedthrough wires were damaged at explant during attempts to loosen the stuck high voltage setscrew.Analysis noted that based upon what was seen in the field, the setscrew was stuck up inside the capture washer, however upon receipt for analysis the setscrew was loose and operated normally.

• 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; cashel road; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16539910
• Report Number: 2124215-2023-12017
• Device Sequence Number: 15280303
• Product Code: LWS
• UDI-Device Identifier: 00802526562808
• UDI-Public: 00802526562808
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: 2020
• 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): 03/14/2023

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: 04/25/2015
• Device Model Number: 1010
• Device Catalogue Number: 1010
• Device Lot Number: A010891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Female