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

Model Number CDHFA500Q

Device Problems High impedance (1291); Loose or Intermittent Connection (1371); Failure to Disconnect (2541); Connection Problem (2900)

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

Event Date 02/19/2021

Event Type  malfunction  

Event Description

During an implant procedure, both a high pacing impedance and a high defibrillation impedance were observed on the device.The right ventricular (rv) lead was attempted to be disconnected from the device, but had difficulties being removed from the header.The rv lead was able to be successfully disconnected and then was attempted to be re-inserted into the header, but was unable to be re-connected.The device was explanted and replaced to resolve the event.The patient was stable and will continue to be monitored.

Manufacturer Narrative

The reported field events of a set screw connection issue and high pacing lead impedance (pli) were verified, however, these events were consistent with the procedure.The right ventricular (rv) df4 set screw was revealed to be completely backed out from the set screw thread, which is a result of unscrewing the set screw too far.When the screw was re-engaged with the connector block, the screw operated normally in affixing the test lead to the header.It is believed that the high pli observed in the field was likely due to the lead connection issue.Interrogation of the device revealed the device was above elective replacement indicator (eri) when received.Telemetry, pacing, sensing, impedance, high voltage (hv) output, hv shock, and patient notifier were all tested on the bench and no anomalies were detected.

Event Description

Additional information was received that the set screw was stripped.

• Brand Name: GALLANT HF
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11447217
• MDR Text Key: 238895664
• Report Number: 2017865-2021-11362
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032010
• UDI-Public: 05415067032010
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2021

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 Expiration Date: 08/31/2022
• Device Model Number: CDHFA500Q
• Device Catalogue Number: CDHFA500Q
• Device Lot Number: S000077807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2021
• Initial Date FDA Received: 03/09/2021
• Supplement Dates Manufacturer Received: 05/29/2021; 06/24/2021
• Supplement Dates FDA Received: 06/04/2021; 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1