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

Model Number	CD1231-40Q
Medical Device Problem Codes	Failure to Convert Rhythm (1540); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	10/13/2023
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: 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
• Report Number: 2017865-2023-50745
• Device Sequence Number: 7537765
• Product Code: NVZ
• UDI-Device Identifier: 05414734504348
• UDI-Public: 05414734504348
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown