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); Incorrect Measurement (1383); Pacing Problem (1439); Interrogation Problem (4017)

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

Event Type  malfunction  

Event Description

It was reported that the patient presented in clinic for a follow up.Device interrogation revealed incorrect measurement on the implantable cardioverter defibrillator (icd).No changes or intervention were reported.The patient condition was unknown.

Event Description

It was reported that the implantable cardioverter defibrillator (icd) displayed abnormal pacing behavior.Then, it was discovered that the device parameters had changed from the programmed settings, and was reprogrammed to the nominal setting, which fixed the abnormal pacing behavior.Later, it was attempted to pair the icd with the monitoring application, but the application would not 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 failed.Eventually, the pairing was successful, but a manual transmission could not be sent.A few days later, it was seen that the app was connected to the device.The patient condition was unknown.

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 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: 18341344
• MDR Text Key: 330679415
• Report Number: 2017865-2023-94893
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• 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: A000146672
• 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?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2023
• 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: 7120Q/58.; MERLIN MYPULSE APP.
• Patient Age: 59 YR
• Patient Sex: Male