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

Model Number CDHFA500Q

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Contamination of Device Ingredient or Reagent (2901)

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

Event Date 04/21/2023

Event Type  Injury  

Event Description

Related manufacturer reference numbers: 2017865-2023-19007.It was reported that the patient presented in clinic for right atrial (ra) lead revision.It was previously noted that chest x-ray was performed and revealed ra lead dislodgement.During ra lead revision procedure, it was found that a set screw of the implantable cardioverter defibrillator (icd) exhibited engagement issue with the hex wrench and failure to tighten down a lead after being removed.The ra lead and the icd were both explanted and replaced.Patient condition was stable.

Event Description

New information received notes that the implantable cardioverter defibrillator (icd) was migrated, which had caused the right atrial lead to dislodge.During procedure, septum material was also found around the icd set screw and the set screw was found to be stripped as well.

Manufacturer Narrative

The reported event of set screw anomaly was confirmed.Septum material was observed inside the set screw hex cavity, and the set screw was slightly stripped.This material in the hex cavity prevented full insertion of the torque driver and was the cause of the reported event.No other anomalies were found.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.

• 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: 16857162
• MDR Text Key: 314465268
• Report Number: 2017865-2023-19008
• 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: 07/12/2023

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 Expiration Date: 11/30/2023
• Device Model Number: CDHFA500Q
• Device Catalogue Number: CDHFA500Q
• Device Lot Number: S000084952
• 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: 04/21/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 06/22/2023; 07/10/2023
• Supplement Dates FDA Received: 06/29/2023; 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2021
• 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.; RV LEAD.
• Patient Age: 70 YR
• Patient Sex: Female