MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY DR, U1.6 DF1 US; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number CD2231-40

Device Problems Incorrect Measurement (1383); Environmental Compatibility Problem (2929); Inappropriate or Unexpected Reset (2959)

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

Event Date 09/12/2023

Event Type  Injury  

Event Description

It was reported that the patient presented in clinic for follow-up.Upon interrogation, was found that the implantable cardioverter defibrillator (icd) had went into backup operation due to magnetic resonance imaging performed for the unconventional system, the device image functionality was also found damaged and cannot be reset.Programming changes were made, and the icd was restored, but without the device image.Patient condition was stable.

Manufacturer Narrative

The reported field event of reset was confirmed.The reset was caused by exposure to magnetic resonance imaging (mri) in the field.After the device was restored from reset, functional testing was performed.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.

Event Description

New information received notes that the implantable cardioverter defibrillator was explanted and replaced.Patient condition was stable pre, during, and post procedure.

• Brand Name: FORTIFY DR, U1.6 DF1 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: 17778134
• MDR Text Key: 324133258
• Report Number: 2017865-2023-46531
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: CD2231-40
• Device Lot Number: A000107680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 10/18/2023; 12/08/2023
• Supplement Dates FDA Received: 10/23/2023; 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2021
• 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
• Patient Outcome(s): Required Intervention