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

Model Number CDVRA500Q

Device Problems Over-Sensing (1438); Defective Device (2588); Contamination of Device Ingredient or Reagent (2901)

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

Event Date 06/05/2023

Event Type  malfunction  

Event Description

During the initial implant procedure, noise resulting in oversensing was noted on the right ventricular channel when the right ventricular lead was connected to the header of the device.Upon investigation, blood was noted inside the lead port of the device.The port was cleaned, and the lead was reconnected; however, the noise persisted.A header anomaly was suspected.The device was replaced, and the implant procedure was completed without further complications.The patient was in stable condition.

Manufacturer Narrative

The reported event of sensing, noise, and header anomaly could not be confirmed.Interrogation of the device revealed the device was above elective replacement indicator (eri) when received.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.

• Brand Name: GALLANT VR
• 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: 17136618
• MDR Text Key: 317269567
• Report Number: 2017865-2023-23323
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067031990
• UDI-Public: 05415067031990
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 09/21/2023

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: CDVRA500Q
• Device Catalogue Number: CDVRA500Q
• Device Lot Number: P000162254
• 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: 06/05/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 09/14/2023
• Supplement Dates FDA Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2023
• 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