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

Model Number CDHFA500Q

Device Problem Failure to Interrogate (1332)

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

Event Date 03/11/2024

Event Type  malfunction  

Event Description

It was reported that the implantable cardioverter defibrillator exhibited bluetooth telemetry loss.The patient was seen in clinic and the pairing was restored.There were no patient consequences reported.

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 and resulted in the loss of ble connectivity.

• Brand Name: GALLANT HF
• 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: 19022665
• MDR Text Key: 339152129
• Report Number: 2017865-2024-37463
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032010
• UDI-Public: (01)05415067032010(10)S000083560(17)230831
• 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: Consumer,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2024

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: 08/31/2023
• Device Model Number: CDHFA500Q
• Device Lot Number: S000083560
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 05/09/2024; 05/23/2024
• Supplement Dates FDA Received: 05/23/2024; 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2021
• 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: LV LEAD; OPTISURE MRI; TENDRIL
• Patient Age: 87 YR
• Patient Sex: Male