MAUDE Adverse Event Report: ABBOTT GALLANT HF; NO MATCH

Model Number CDHFA500Q

Device Problems Product Quality Problem (1506); Connection Problem (2900)

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

Event Date 11/22/2023

Event Type  malfunction  

Event Description

During attempted implant, it was reported that the lead could not be inserted into the header of the device.The header of the device appeared cloudy.A different device was successfully implanted to resolve the event.The patient was stable and there were no adverse consequences.

Manufacturer Narrative

The reported field event of header discoloration was confirmed.Interrogation of the device revealed the device was above eri when received.The reported event of failure to connect could not be reproduced in lab.Visual inspection of the septum, setscrew and contact spring did not reveal any anomaly that could contribute to the reported event.

• 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: 18369863
• MDR Text Key: 331046554
• Report Number: 2017865-2023-95268
• 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: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDHFA500Q
• Device Lot Number: P000179750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2023
• 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