MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT HF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CDHFA500Q

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Failure to Sense (1559); Under-Sensing (1661); Use of Device Problem (1670); Defective Device (2588)

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

Event Date 02/01/2023

Event Type  malfunction  

Event Description

It was reported a patient presented for an implant procedure on (b)(6) 2023.During procedure it was noted the implantable cardioverter defibrillator (icd) right ventricular port did not work.There was also noise, under-sensing, and loss of capture noted.The device was not used and replaced within the same operation.Post-procedure the patient was stable.

Manufacturer Narrative

The reported field events of connection anomaly, capture and sensing issues could not be reproduced in the lab.Upon receipt, the device was above elective replacement indicator (eri).Visual inspection of the septum, setscrew and contact spring did not reveal any anomaly.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.

Event Description

New information received notes the implantable cardioverter defibrillator (icd) presented with no sensing in the right ventricular (rv) port and an inability to be implanted due to an unspecified product-related problem.The patient was stable.

• Brand Name: GALLANT HF
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16372613
• MDR Text Key: 309498978
• Report Number: 2017865-2023-08866
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032010
• UDI-Public: 05415067032010
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2023

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: S000088669
• 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: 02/01/2023
• Initial Date FDA Received: 02/14/2023
• Supplement Dates Manufacturer Received: 02/17/2023; 03/10/2023
• Supplement Dates FDA Received: 02/22/2023; 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2022
• 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
• Patient Age: 71 YR
• Patient Sex: Male