MAUDE Adverse Event Report: ABBOTT GALLANT HF; NO MATCH

Model Number CDHFA500Q

Device Problems High impedance (1291); Loose or Intermittent Connection (1371); Device Sensing Problem (2917)

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

Event Date 07/29/2023

Event Type  malfunction  

Event Description

During an initial implant procedure, it was difficult to secure the set screw with torque wrench.When measurements were taken on the device, a decrease in sensing and increase in pacing impedance were observed.A new device was successfully implanted to resolve the event.The patient was stable.

Manufacturer Narrative

The reported event of setscrew, impedance, and sensing anomaly could not be confirmed.The device was above elective replacement indicator (eri) upon receipt.Analysis revealed the right ventricular setscrew was partially stripped and contained septum material inside their hex cavities.However, the setscrew wasn¿t fully stripped to the extent where it wasn¿t able to be engaged by the torque driver.The damage to the setscrew was consistent with having occurred during the procedure.

• 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: 17515531
• MDR Text Key: 321045371
• Report Number: 2017865-2023-38113
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• 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: P000171469
• 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: 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2023
• 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