MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORIGEN X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number	G058
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	09/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a device change out procedure and unknown right ventricular (rv) lead revision with high impedances, the set screw for the left ventricular (lv) lead was unable to be unscrewed.The header had to be cutoff and the left ventricular (lv) lead had to be replaced.All new measured values were stable.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that during a device change out procedure and unknown right ventricular (rv) lead revision with high impedances, the setscrew for the left ventricular (lv) lead was unable to be unscrewed.The header had to be cutoff and the left ventricular (lv) lead had to be replaced.All new measured values were stable.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that during a device change out procedure and unknown right ventricular (rv) lead revision with high impedances, the setscrew for the left ventricular (lv) lead was unable to be unscrewed.The header had to be cutoff and the left ventricular (lv) lead had to be replaced.All new measured values were stable.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual inspection noted the header was cut in line with the lv connector blocks.The lv set screw terminal block was missing.The lv seal plug was observed to still be in the lv lead barrel.The right atrial section of the header was returned.The remaining seal plugs and set screws operate normally.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.The device was intentionally damaged in an attempt to remove the lv lead from the header.

• Brand Name: ORIGEN X4 CRT-D
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12749851
• Report Number: 2124215-2021-29723
• Device Sequence Number: 4550844
• Product Code: NIK
• UDI-Device Identifier: 00802526534515
• UDI-Public: 00802526534515
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P010012/S341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2023

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: Health Professional
• Device Expiration Date: 02/25/2021
• Device Model Number: G058
• Device Catalogue Number: G058
• Device Lot Number: 210324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 10/29/2021; 05/04/2023
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 12/19/2021; 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown