MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY ASSURA DR ICD, US; Pulse generator, permanent, implantable

Model Number CD2357-40Q

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/25/2023

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2023-44072 / 2017865-2023-44074 it was reported that the patient presented for a scheduled generator upgrade procedure.During the procedure, the implantable cardioverter defibrillators set screw appeared stripped and could not be loosened.While attempting to remove the atrial lead from the device's header, the lead pin was damaged and appeared sprung.Ultimately, the lead was capped and replaced on (b)(6) 2023.The device was replaced.After the procedure on the same day, the patient developed bleeding at the pocket site and underwent another successful procedure for reconciliation of the bleeding.The patient tolerated the procedure well and was in stable condition.

• 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: 17795169
• MDR Text Key: 324001743
• Report Number: 2017865-2023-46693
• Device Sequence Number: 1
• Product Code: NVZ
• 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
• Report Date: 09/21/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: CD2357-40Q
• Device Lot Number: P000167410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2023
• 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: DURATA TACHY; TENDRIL
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 73 KG