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

Model Number CDDRA500Q

Device Problems Loose or Intermittent Connection (1371); Failure to Disconnect (2541)

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

Event Date 02/15/2022

Event Type  Injury  

Event Description

During the initial implant procedure when attempting to attach the ventricular lead to the device, the set screw could not be fully tightened.The set screw could then not be loosened to release the lead.A set screw malfunction was suspected.The device was replaced and the implant procedure was successfully completed.The patient was in stable condition.

Event Description

During a routine device exchange procedure on (b)(6) 2022, the set screw of the replacement device could not be fully tightened.The physician then attempted to disconnect the right ventricular (rv) lead from the header of the device, but was unable to loosen the set screw.A device malfunction was suspected.The rv lead was cut, the device was removed, and no device was implanted.The patient was given a zoll lifevest wearable cardioverter defibrillator as a temporary solution.On (b)(6) 2022, an additional procedure was performed to explant the rv lead, and a replacement device and rv lead were successfully implanted.The patient was in stable condition.

Manufacturer Narrative

The reported event of set screw connection issue was confirmed.The set screws were found to be completely backed out from the set screw thread as a result of unscrewing the set screw too far.The issue was consistent with the procedure.The header was severely damaged prior to analysis.The device was above elective replacement indicator (eri) upon receipt.The device history record (dhr) did not show any anomalies.No testing could be performed due to the extent of damage to the header.

• Brand Name: GALLANT DR
• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13568731
• MDR Text Key: 286111281
• Report Number: 2017865-2022-03710
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032003
• UDI-Public: 05415067032003
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: CDDRA500Q
• Device Catalogue Number: CDDRA500Q
• Device Lot Number: P000137938
• 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: 04/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention