MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY ASSURA DR ICD, US; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number CD2357-40C

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

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

Event Date 09/13/2023

Event Type  Injury  

Event Description

It was reported the patient's implantable cardioverter defibrillator (icd) presented with high defibrillation impedance.This was addressed in a procedure on 13 sep 2023 in which the header presented with failure to connect the right ventricular (rv) lead port.The icd was explanted and replaced within the same operation.Post-procedure the patient was discharged.

Manufacturer Narrative

Correction: return not received, appropriate codes inputted.

Manufacturer Narrative

The reported field events of lead connection issue and high impedance were confirmed.Interrogation of the device revealed the device was above elective replacement indicator (eri) upon receipt.Testing in the laboratory confirmed that the rv set screw was not able to secure a test lead.Investigation analysis confirmed a manufacturing related header anomaly.The high lead impedance was consistent with the lead not being secured properly due to the header anomaly.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 DR ICD, US
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 17827712
• MDR Text Key: 324397153
• Report Number: 2017865-2023-47141
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734508063
• UDI-Public: 05414734508063
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• 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: 03/28/2024

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: CD2357-40C
• Device Lot Number: P000162034
• 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: 09/13/2023
• Initial Date FDA Received: 09/27/2023
• Supplement Dates Manufacturer Received: 11/15/2023; 03/27/2024
• Supplement Dates FDA Received: 11/15/2023; 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2023
• 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: ATRIAL LEAD.; RIGHT VENTRICULAR (RV) LEAD.
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male