MAUDE Adverse Event Report: ABBOTT GALLANT HF; NO MATCH

Model Number CDHFA500Q

Device Problems Therapy Delivered to Incorrect Body Area (1508); Impedance Problem (2950); Data Problem (3196)

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

Event Date 11/27/2023

Event Type  Injury  

Event Description

The patient presented in-clinic after reporting daily auditory patient notifications coming from the device.The patient also reported extra cardiac stimulation around the same time the device alerts were given.Upon investigation, the cause of the auditory alerts could not be confirmed.An impedance anomaly was noted as the device was not recording impedance measurements.Abbott technical support was contacted, and the device was initially reprogrammed.After further investigation, evidence of memory corruption was noted in the device memory.The physician then elected to explant and replace the device to resolve the event.The patient was in stable condition.

Manufacturer Narrative

The reported event of impedance anomaly and data corruption was confirmed.Analysis of device image found the device exhibited data corruption due to an integrated circuit (ic) anomaly.Interrogation of the device revealed the device was above elective replacement indicator (eri) when received.After the device¿s product code was restored, functional testing was performed.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.

• Brand Name: GALLANT HF
• Type of Device: NO MATCH
• 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: 18326054
• MDR Text Key: 330494470
• Report Number: 2017865-2023-94805
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032010
• UDI-Public: 05415067032010
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDHFA500Q
• Device Lot Number: P000182807
• 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: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2023
• 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