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

Model Number CDHFA500Q

Device Problems Premature Discharge of Battery (1057); Delayed Charge Time (2586)

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

Event Type  Injury  

Event Description

It was reported that a patient presented with long changed time noted on the patient's implantable cardioverter defibrillator.No intervention or adverse patient consequences were reported.

Manufacturer Narrative

Further information was requested, but not received.

Manufacturer Narrative

Correction: h6: codes should reflect product not returned.

Event Description

New information received notes that a new malfunction of premature battery depletion was noted.The device was explanted and replaced on 28 sep 2023.No further adverse patient consequences were reported.

Manufacturer Narrative

The reported field event of charge timeout was confirmed.Review of device data showed the device had a charge timeout during capacitor maintenance.A capacitor maintenance was performed in the laboratory, and the device had a charge timeout.However, the failure mode was lost during testing and could not be reproduced.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.The cause of the charge time out was found to be a hybrid anomaly.

• 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: 17365344
• MDR Text Key: 319448770
• Report Number: 2017865-2023-36342
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: CDHFA500Q
• Device Catalogue Number: CDHFA500Q
• Device Lot Number: S000084952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/03/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 09/18/2023; 09/28/2023; 05/24/2024
• Supplement Dates FDA Received: 09/18/2023; 10/18/2023; 05/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female