MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT VR; NO MATCH

Model Number CDVRA500Q

Device Problems Use of Incorrect Control/Treatment Settings (1126); Pacing Problem (1439); Interrogation Problem (4017)

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

Event Date 11/27/2023

Event Type  malfunction  

Event Description

It was reported that the patient was presented for an implant procedure.During the procedure, after the implantable cardioverter defibrillator (icd) was connected to the lead, unknown pacing behavior was observed, where the ventricular pacing at a much shorter interval.Then, it was discovered that the sensitivity parameter had changed from the programmed parameter, and was reprogrammed to the nominal setting, which fixed the abnormal pacing behavior.Later, during post-operation interrogation, upon review of the parameters, it was found that the post-shock pacing setting was turned off, a change that was not intentionally made, and it was programmed back on.Finally, it was attempted to pair the icd with the monitoring application.After some difficulty, the application was paired to the device, but attempts to send a transmission failed as the application was unable to connect to the icd.The device was reinterrogated and it was observed that the bluetooth for remote monitoring was turned off and it was confirmed that the setting had not been touched.The setting was turned on, but subsequent attempts to connect the icd to the app and send a transmission failed.There were no patient consequences.

Manufacturer Narrative

The reported event of phantom programming was not confirmed.Based on the information provided, no phantom programming occurred.The reported event of unable to pair with application was confirmed.Based on the information provided, it was determined that when the device was taken out of ship settings, the normal advertising was not set to 2 minutes, resulting in the connectivity issue.

• Brand Name: GALLANT VR
• 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: 18385773
• MDR Text Key: 331242021
• Report Number: 2017865-2023-95468
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067031990
• UDI-Public: 05415067031990
• 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: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDVRA500Q
• Device Lot Number: A000137310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2023
• 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: DURATE TACHY MRI LEAD; MERLIN APP
• Patient Age: 62 YR
• Patient Sex: Male