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

Model Number CDHFA500Q

Device Problems Failure to Interrogate (1332); Interrogation Problem (4017)

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

Event Type  malfunction  

Manufacturer Narrative

Further information was requested but not received.

Event Description

It was reported that the implantable cardioverter defibrillator exhibited a bluetooth telemetry issue.No intervention was performed.The patient condition was unknown.

Event Description

New information received indicates that the device was unable to pair to the mobile application due to a possible bluetooth malfunction.A ble reset was performed.The patient was in stable condition.

Manufacturer Narrative

The reported event of inability to communicate via ble was confirmed.Based on the review of the information provided, it was confirmed that a memory corruption had occurred, resulting in the loss of ble connectivity.

• Brand Name: GALLANT HF
• 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: 16849969
• MDR Text Key: 314387445
• Report Number: 2017865-2023-18864
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032010
• UDI-Public: 05415067032010
• 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,Followup
• Report Date: 10/13/2023

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: 10/31/2023
• Device Model Number: CDHFA500Q
• Device Catalogue Number: CDHFA500Q
• Device Lot Number: S000084240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2023
• Initial Date FDA Received: 05/01/2023
• Supplement Dates Manufacturer Received: 05/04/2023; Not provided
• Supplement Dates FDA Received: 05/09/2023; 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2021
• 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: 1458Q/86 QUARTETLEADS; 7122Q/58 DURATATACHY MRI LEADS
• Patient Age: 86 YR
• Patient Sex: Male