MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY QUADRA CRT-D, US MODEL, DF4COMP; NO MATCH

Model Number	CD3249-40Q
Medical Device Problem Codes	Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pocket Erosion (2013); Discomfort (2330)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient presented with a pocket ulcer.Their implantable cardioverter defibrillator (icd) was explanted in a procedure on (b)(6) 2023.During the procedure, the left ventricular lead set screw slipped and the silicone pad was damaged before pulling out the lead.Post-procedure the patient was stable.
Additional Manufacturer Narrative
The reported field event of set screw anomaly was confirmed.Analysis of the device revealed the left ventricular set screw was detached from its setscrew bore.The lv setscrew could be over loosened causing the setscrew to dislodge from the setscrew bore.The issue was consistent with having occurred during the procedure.The device was above elective replacement indicator (eri) when received.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.Review of the sterilization records confirmed normal sterilization cycles for the products.The cause of infection could not be determined.
Event or Problem Description
Related manufacturer reference number: 2017865-2023-37147.Related manufacturer reference number: 2017865-2023-37148.Related manufacturer reference number: 2017865-2023-37150.It was reported a patient presented with a pocket ulcer with swelling and pain at the pocket.When the patient came for treatment on (b)(6) 2023, the physician found the lead was exposed and the patient had an infection.Their system was explanted in a procedure on (b)(6) 2023.During the procedure, the implantable cardioverter defibrillator (icd) left ventricular set screw slipped and the silicone pad was damaged before pulling out the lead.Post-procedure the patient was stable.

• Brand Name: UNIFY QUADRA CRT-D, US MODEL, DF4COMP
• Common Device Name: NO MATCH
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17390478
• Report Number: 2017865-2023-36656
• Device Sequence Number: 15681865
• Product Code: NIK
• UDI-Device Identifier: 05414734504546
• UDI-Public: 05414734504546
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2023

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: 02/29/2024
• Device Model Number: CD3249-40Q
• Device Lot Number: A000129289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 07/23/2023; 08/29/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 08/01/2023; 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown