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

Model Number CDDRA500Q

Device Problems Failure to Capture (1081); High impedance (1291); Failure to Sense (1559); Capturing Problem (2891)

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

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2023-00600.It was reported the patient presented remotely via merlin.Net.Review of the transmission revealed the right ventricular lead exhibited high pacing impedance, high defibrillation impedance, low to no sensing of r-waves, and a change in capture threshold.During surgery, the physician found the terminal pen was loose and able to be moved.The right ventricular lead was explanted and replaced.Upon connection to the implantable cardioverter defibrillator (icd), the issues persisted.The icd was explanted and replaced.The patient was in stable condition.

Event Description

New information noted the implantable cardioverter defibrillator (icd) and right ventricular lead exhibited a failure to capture.The patient was in stable condition.

Manufacturer Narrative

A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.The reported events of failure to capture, failure to sense, high pacing impedance and high defibrillation impedance were confirmed.The implantable cardioverter defibrillator (icd) was returned for analysis.The cause of the anomalies was determined to be due to an anomalous integrated circuit.

• Brand Name: GALLANT DR
• 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: 16118809
• MDR Text Key: 306877621
• Report Number: 2017865-2023-00600
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032003
• UDI-Public: 05415067032003
• 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,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDDRA500Q
• Device Catalogue Number: CDDRA500Q
• Device Lot Number: S000088512
• 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: 12/20/2022
• Initial Date FDA Received: 01/06/2023
• Supplement Dates Manufacturer Received: 01/06/2023; 04/26/2023; 03/18/2024
• Supplement Dates FDA Received: 01/25/2023; 04/27/2023; 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2022
• 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
• Treatment: TENDRIL STS
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male