MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY VR, U1.6 DF1 US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD1231-40

Device Problems Failure to Interrogate (1332); Inappropriate or Unexpected Reset (2959); No Pacing (3268)

Patient Problems Arrhythmia (1721); Discomfort (2330); Syncope/Fainting (4411)

Event Date 01/29/2023

Event Type  Injury  

Event Description

It was reported that the patient presented in clinic for follow-up after a syncopal event.Upon review, the implantable cardioverter defibrillator was found on backup mode.The device could not be restored as communication with the programmer was lost.The device was not pacing in backup mode, and the patient was uncomfortable with bradycardia as a result.The device was explanted and replaced.The patient was recovering.

Manufacturer Narrative

The reported field event of backup vvi, telemetry anomaly, and no pacing output was confirmed.Analysis of device image found the device went into backup mode due to a power-on-reset (por).The por, telemetry anomaly, and no pacing output were caused by low battery voltage.The low battery voltage was due to device usage resulting from the patient's repetitive high voltage therapies delivered in a short period of time.After the device was restored from backup mode, functional testing was performed and found normal.

• Brand Name: FORTIFY VR, U1.6 DF1 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: 16312486
• MDR Text Key: 308946219
• Report Number: 2017865-2023-05261
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734504355
• UDI-Public: 05414734504355
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: CD1231-40
• Device Catalogue Number: CD1231-40
• Device Lot Number: S000069867
• 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: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2019
• 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