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

Model Number CD3249-40

Device Problems Premature Discharge of Battery (1057); Incorrect Interpretation of Signal (1543); Inappropriate/Inadequate Shock/Stimulation (1574); Inappropriate or Unexpected Reset (2959); Interrogation Problem (4017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 326905301
• Report Number: 2017865-2023-51149
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734504539
• UDI-Public: 05414734504539
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention