MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY QUADRA CRT-D, US MODEL, DF1COMP; NO MATCH

Model Number	CD3249-40
Medical Device Problem Code	No Pacing (3268)
Health Effect - Clinical Codes	Syncope/Fainting (4411); Embolism/Embolus (4438)
Date of Event	11/21/2023
Type of Reportable Event	Death
Event or Problem Description
Related manufacturer reference numbers: 2017865-2023-94481; related manufacturer reference numbers: 2017865-2023-94484; related manufacturer reference numbers: 2017865-2023-94485; related manufacturer reference numbers: 2017865-2023-94486; related manufacturer reference numbers: 2017865-2023-94487.It was reported that the patient presented in clinic for initial implant procedure.During procedure, it was found that the newly placed right atrial (ra) exhibited high capture threshold and high pacing impedance and the newly placed implantable cardioverter defibrillator (icd) exhibited failure to pace.The ra lead and the icd were not implanted and alternates near at hand were implanted instead on (b)(6) 2023 to complete the procedure.Post procedure, the patient went into a coma and eventually passed away due to acute pulmonary embolism.
Additional Manufacturer Narrative
The reported event of pacing issue was not confirmed in lab.Visual inspection of the septum and setscrew did not reveal any anomaly that could contribute to the reported event.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.

• Brand Name: UNIFY QUADRA CRT-D, US MODEL, DF1COMP
• 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: 18307454
• Report Number: 2017865-2023-94483
• Device Sequence Number: 6615586
• Product Code: NIK
• UDI-Device Identifier: 05414734504539
• UDI-Public: 05414734504539
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2024

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: 10/31/2024
• Device Model Number: CD3249-40
• Device Lot Number: A000141274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2023
• 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: Death
• Patient Sex: Unknown