MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY VR, U1.6 SJ4 US; Pulse generator, permanent, implantable

Model Number CD1231-40Q

Device Problems Failure to Convert Rhythm (1540); Inappropriate or Unexpected Reset (2959)

Patient Problem Arrhythmia (1721)

Event Date 10/13/2023

Event Type  Injury  

Event Description

It was reported that the patient presented in hospital with sustained ventricular tachycardia.It was believed by the physician that the implantable cardioverter defibrillator (icd) exhibited inadequate high voltage therapy.External defibrillation was performed to convert the rhythm.Upon interrogation for programming changes, it was found that the icd had gone into backup operation due to unknown reason.The icd was not restored, and medication treatment was prescribed.Patient condition was stable.

• Brand Name: FORTIFY VR, U1.6 SJ4 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: 18014188
• MDR Text Key: 326640107
• Report Number: 2017865-2023-50745
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734504348
• UDI-Public: 05414734504348
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/26/2023

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: 05/31/2021
• Device Model Number: CD1231-40Q
• Device Lot Number: A000090184
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2019
• 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): Other