MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY ASSURA VR ICD, US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number CD1359-40QC

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 11/21/2023

Event Type  malfunction  

Event Description

Related manufacturing reference number: 2017865-2023-93805.It was reported that the patient presented for a follow-up in clinic.It was noted that the patient had received several inappropriate shocks due to the right ventricular (rv) lead over-sensing noise.Additionally, the rv lead was also not capturing.It was confirmed that the rv lead perforated the heart.The physician attempted to reposition the rv lead, but the set screw of the implantable cardioverter defibrillator (icd) became loose during the procedure, which made it difficult to connect any lead.The physician elected to replace the icd and did so successfully.The same rv lead was repositioned successfully on (b)(6) 2023.The patient was stable throughout the procedure.

Manufacturer Narrative

The reported field event of stripped setscrew anomaly was confirmed.The device was above elective replacement indicator (eri) when received.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.Analysis of the device revealed the right ventricular setscrew was detached from its setscrew bore.The rv setscrew could be over loosened causing the setscrew to dislodge from the setscrew bore.The issue was consistent with having occurred during the procedure.The cause of stripped setscrew is most likely due to applying pressure to tighten the setscrew while the torque driver was not fully insert into the hex cavity.

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.

• Brand Name: FORTIFY ASSURA VR ICD, US
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 18263686
• MDR Text Key: 329715058
• Report Number: 2017865-2023-93804
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD1359-40QC
• Device Lot Number: P000168420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2023
• 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