MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CDDRA500Q

Device Problems Inappropriate or Unexpected Reset (2959); Interrogation Problem (4017)

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

Event Date 03/29/2023

Event Type  Injury  

Event Description

It was reported that the patient presented post implantable cardioverter defibrillator (icd) implant procedure.Upon interrogation, it was noted the the icd lost bluetooth connection.The programmer was rebooted and the device was able to be interrogated.It was then noted the device was in backup mode.The device was unable to be restored and was explanted and replaced.The patient was in stable condition.

Manufacturer Narrative

The reported events of backup operation, ble (bluetooth) telemetry issue, and an error message were confirmed.Final analysis found that the device was in backup vvi and in this state, ble telemetry is not accessible.When interrogated as received on the bench, an error message was observed.Analysis of device image found the device went into backup mode due to memory error.After the device was restored from backup mode, functional testing was performed.Telemetry (ble and inductive), impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.The backup operation could not be reproduced.The cause of the reported event could not be determined.

• Brand Name: GALLANT DR
• Type of Device: 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: 16756370
• MDR Text Key: 313476371
• Report Number: 2017865-2023-17776
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032003
• UDI-Public: 05415067032003
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDDRA500Q
• Device Catalogue Number: CDDRA500Q
• Device Lot Number: S000087003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2022
• 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
• Treatment: 2088TC/52 TENDRIL LEADS; 7122Q/65 DURATA TACHY MRI LEADS
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male