MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY VR, U1.6 SJ4 US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD1231-40Q

Device Problems Incorrect Interpretation of Signal (1543); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Insufficient Information (4580)

Event Date 09/29/2022

Event Type  Injury  

Event Description

It was reported that the patient presented for replacement of the implantable cardioverter defibrillator.It was noted that the patient had a history of atrial fibrillation with a rapid ventricular response for which inappropriate shocks were delivered.The device was successfully explanted and replaced with a dual-chamber generator.There were no patient consequences.

Manufacturer Narrative

The reported event of inappropriate therapy could not be confirmed.Interrogation of the device revealed the device was at elective replacement indicator (eri) when received.A longevity calculation was performed and found the battery depletion was normal based on the device usage.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.

• Brand Name: FORTIFY VR, U1.6 SJ4 US
• 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: 15811457
• MDR Text Key: 303792268
• Report Number: 2017865-2022-45662
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734504348
• UDI-Public: 05414734504348
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2012
• Device Model Number: CD1231-40Q
• Device Catalogue Number: CD1231-40Q
• Device Lot Number: 3172601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2010
• 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.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 51 KG