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

Model Number CDHFA500Q

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900); Contamination of Device Ingredient or Reagent (2901)

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

Event Date 05/26/2023

Event Type  malfunction  

Event Description

During initial implant procedure, the lead was not able to fit into the device header due to a metallic piece in the connector blocking the lead.The set screw was unable to be moved.A new device was selected and successfully implanted to resolve the event.The patient was stable.

Manufacturer Narrative

The reported field event of lead connection issue was confirmed.Visual analysis shows the atrial ring spring was dislodged and pushed into the atrial lead bore.

• 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: 17140798
• MDR Text Key: 317295671
• Report Number: 2017865-2023-23390
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032010
• UDI-Public: 05415067032010
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 09/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDHFA500Q
• Device Catalogue Number: CDHFA500Q
• Device Lot Number: P000157580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/26/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 09/01/2023
• Supplement Dates FDA Received: 09/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2022
• 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