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

Model Number CDHFA500Q

Device Problems High impedance (1291); Connection Problem (2900)

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

Event Date 04/04/2023

Event Type  malfunction  

Manufacturer Narrative

The reported event of header anomaly could not be confirmed.Visual inspection, telemetry, impedance, sensing, pacing and output functions of the device were normal with no anomalies found.

Event Description

Related manufacturer reference numbers: 2017865-2023-18227.It was reported that the patient presented in clinic for generator change.During procedure on (b)(6) 2023, it was found that a competitive right ventricular lead was unable to be inserted fully into the implantable cardioverter defibrillator (icd) header.The icd was not implanted and a replacement near at hand was used.The replacement icd also exhibited the same issue.The replacement icd was not implanted as well, and the original implanted icd was re-implanted to complete the procedure.Patient condition was stable.

Event Description

It was also noted that during the procedure, both the pacing and defibrillation impedance were found high and out-of-range for the two replacement implantable cardioverter defibrillators.

Event Description

Related manufacturer reference numbers: 2017865-2023-18227.Related manufacturer reference numbers: 2017865-2023-19573.New information received notes that the original replacement of implantable cardioverter defibrillator was due to patient discomfort.

• 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: 16792530
• MDR Text Key: 313807186
• Report Number: 2017865-2023-18226
• 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: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2023
• 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: S000089567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2023
• 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
• Treatment: QUARTET.; RA LEAD.; RV LEAD.
• Patient Age: 88 YR
• Patient Sex: Female