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

Model Number CDHFA500Q

Device Problems Incorrect Interpretation of Signal (1543); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Therapeutic Effects, Unexpected (2099); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2020

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

During a remote follow-up, inappropriate high voltage therapy was delivered due to an incorrect interpretation of the signal.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 the device was reprogrammed to resolve the event.

Manufacturer Narrative

The complaint of vf detection occurring when the displayed value of the detected intervals (262 ms) were greater than the programmed vf detection interval of 260 ms was confirmed.The findings indicate that the device was functioning per programming as both the programmed interval and the displayed marker interval are rounded.In this case, the programmed interval was rounded down and the displayed marker interval was rounded up, when in reality they were equal.Per the tachycardia devices merlin patient care system help manual, the tolerance for vt/vf detection intervals is +/- 10 ms.The device is functioning per specifications.

• Brand Name: GALLANT HF
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11156118
• MDR Text Key: 226305785
• Report Number: 2017865-2020-25210
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032010
• UDI-Public: 05415067032010
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: CDHFA500Q
• Device Catalogue Number: CDHFA500Q
• Device Lot Number: S000076756
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other