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

Model Number CDDRA500Q

Device Problem Failure to Interrogate (1332)

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

Event Date 02/02/2023

Event Type  malfunction  

Event Description

It was reported that the implantable cardioverter defibrillator was unable to pair to the mobile application due to a possible bluetooth malfunction.No intervention was performed.The patient condition was unknown.

Manufacturer Narrative

The reported event of inability to connect via ble was not confirmed.The results of the software analysis are inconclusive since no additional information was obtained to investigate.Based on the information received, the cause of the reported incident could not be conclusively 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: 16432926
• MDR Text Key: 310157064
• Report Number: 2017865-2023-10760
• 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: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: CDDRA500Q
• Device Catalogue Number: CDDRA500Q
• Device Lot Number: P000145138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2023
• Initial Date FDA Received: 02/23/2023
• Supplement Dates Manufacturer Received: 07/26/2023
• Supplement Dates FDA Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2022
• 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/58 DURATATACHY MRI LEADS
• Patient Age: 65 YR
• Patient Sex: Female