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

Model Number CDHFA500Q

Device Problems Failure to Interrogate (1332); Wireless Communication Problem (3283)

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

Event Date 07/26/2023

Event Type  malfunction  

Manufacturer Narrative

Further information was requested, but not received.

Event Description

It was reported that a patient presented with loss of bluetooth low energy telemetry noted on the patient's implantable cardioverter defibrillator.Corrective intervention was planned.No adverse patient consequences were reported,.

Event Description

New information received notes that the previously reported event of loss of ble telemetry was actually ble lockout.Another occurrence of the ble lockout was reported.Corrective intervention was planned to clear the lockout.No adverse patient consequences were reported.

Manufacturer Narrative

The reported of ble unavailable was resolved by interrogating the device using a merlin programmer, this is indicative of a ble lockout which is per device design.

Event Description

New information received notes that additional corrective intervention was performed to restore the telemetry function of the device.

Manufacturer Narrative

The reported event of consistent ble lockouts were not able to be confirmed based on the session records and patient app logs available for investigation.There were connection timeouts noted in the patient app logs, due to the device not being discovered, but the cause was not able to be determined.The patient reconnected with a byod and has been communicating successfully since.

• 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: 17600171
• MDR Text Key: 321730315
• Report Number: 2017865-2023-39052
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/20/2023

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: CDHFA500Q
• Device Lot Number: P000145135
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/22/2023
• Supplement Dates Manufacturer Received: 08/24/2023; 09/12/2023; 09/29/2023; 12/15/2023
• Supplement Dates FDA Received: 09/12/2023; 09/19/2023; 10/23/2023; 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2022
• 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: OPTISUREMRI.; QUARTETLEADS.; TENDRIL LEADS.
• Patient Age: 76 YR
• Patient Sex: Male