MAUDE Adverse Event Report: ABBOTT GALLANT HF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CDHFA500Q

Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332); No Pacing (3268)

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

Event Date 01/11/2023

Event Type  malfunction  

Event Description

During a clinic follow-up, the device was unable to be interrogated.Technical support was contacted, but no intervention has been performed at this time.The patient was stable and will continue to be monitored.

Event Description

Additional information was received that a loss of pacing was observed on the device and the physician suspects premature battery depletion.Furthermore, the device was explanted and replaced to resolve the event.The patient was stable and will continue to be monitored.

Manufacturer Narrative

The reported event of failure to interrogate was confirmed.Based on the information provided, the device could not be found when interrogated by both merlin1 and merlin2 programmers as bluetooth (ble) and inductive telemetries were unavailable.However, the exact cause of the loss of communication could not be identified with the available data.

Manufacturer Narrative

The reported event of a communication anomaly was confirmed.Upon receipt, the device was unable to communicate due to low battery voltage.The low battery voltage was due to premature battery depletion, as a result of high current consumption in the hybrid.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and revealed to be normal.The cause of the high input current could not be conclusively determined.

• Brand Name: GALLANT HF
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16249524
• MDR Text Key: 308205456
• Report Number: 2017865-2023-04261
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032010
• UDI-Public: 05415067032010
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: CDHFA500Q
• Device Catalogue Number: CDHFA500Q
• Device Lot Number: P000129670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2021
• 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