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 Codes	Premature Discharge of Battery (1057); Incorrect Interpretation of Signal (1543); Inappropriate/Inadequate Shock/Stimulation (1574); Inappropriate or Unexpected Reset (2959); Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, that patient presented in clinic for routine follow-up.Upon evaluation, it was found, that patient's implantable cardioverter defibrillator (icd) was in backup mode.It was also noted, that the patient received inappropriate shock.The device was not able to be interrogated, due to backup mode.Premature battery depletion was suspected.The device was explanted and replaced.The patient was stable.
Additional Manufacturer Narrative
The reported field event of reset was confirmed.Review of the device data showed that firmware had been restored in the field.While the device image showing the reset was not available and returned for analysis, the field reported that the device delivered high voltage therapies prior to the reset and the cause of reset was due to low battery voltage resulting from device usage.The device was confirmed to have reached end of service upon receipt.A longevity calculation was performed and the battery depletion was normal based on the device usage.Memory testing was performed, and no anomalies were found.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: 18033836
• Report Number: 2017865-2023-51149
• Device Sequence Number: 12619628
• 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
• Device Implanted Year: 2017
• 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): 01/02/2024

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: 09/30/2018
• Device Model Number: CD3249-40
• Device Lot Number: S000030712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• 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: Not provided
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2017
• 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