MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY QUADRA CRT-D, US MODEL, DF4COMP; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD3249-40Q
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	01/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented in clinic with the implantable cardioverter defibrillator eroding from his pocket.The entire system was explanted as a result.The patient presented for a device re-implant procedure on (b)(6) 2023.During the procedure, the device was not used as the atrial set screw could not be tighten and a new device was implanted.The patient condition was stable.
Additional Manufacturer Narrative
The reported event of set screw anomaly could not be confirmed.Visual inspection of the septum and setscrew did not reveal any anomaly.A torque driver was able to engage with all set screws normally, and all set screws were able to tighten down and secure a lead normally.Functional testing was found to be normal.

• Brand Name: UNIFY QUADRA CRT-D, US MODEL, DF4COMP
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 16250969
• Report Number: 2017865-2023-04301
• Device Sequence Number: 20183450
• 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: 2022
• 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
• Report Date (Section B): 03/06/2023

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: 12/31/2023
• Device Model Number: CD3249-40Q
• Device Catalogue Number: CD3249-40Q
• Device Lot Number: A000126830
• 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: 01/11/2023
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DURATA; QUARTET; TENDRIL
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown