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 Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented in clinic for a follow-up.Device interrogation revealed premature battery depletion and infection noted on the implantable cardioverter defibrillator (icd).No changes or interventions were performed.There were no patient consequences.
Additional Manufacturer Narrative
Correction: for product not returning.
Event or Problem Description
New information notes that the implantable cardioverter defibrillator (icd) was explanted and replaced.Patient condition is unknown.

• 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: 17687671
• Report Number: 2017865-2023-41106
• Device Sequence Number: 6531609
• Product Code: NVZ
• UDI-Device Identifier: 05414734504348
• UDI-Public: 05414734504348
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2023

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: 03/31/2012
• Device Model Number: CD1231-40Q
• Device Lot Number: 3219151
• 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: 08/16/2023
• Supplement Date Received by Manufacturer: 10/26/2023; 11/01/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 10/26/2023; 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2010
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 7121Q/65 RIGHT VENTRICLE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Male