MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY ASSURA VR ICD_IDE_US; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	CD1257-40Q
Medical Device Problem Codes	Over-Sensing (1438); Incorrect Interpretation of Signal (1543); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, a patient's implantable cardioverter defibrillator (icd) presented with inappropriate anti-tachycardia pacing (atp), due to incorrect interpretation of signal.Programming changes were made to restore normal parameters.There were no patient consequences.
Event or Problem Description
It was reported a patient's implantable cardioverter defibrillator (icd) presented with an inappropriate anti-tachycardia pacing (atp) due to over-sensing noise.Programming changes were made to restore normal parameters.There were no patient consequences.

• Brand Name: FORTIFY ASSURA VR ICD_IDE_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: 17991297
• Report Number: 2017865-2023-50418
• Device Sequence Number: 15496639
• Product Code: NVZ
• UDI-Device Identifier: 05414734505475
• UDI-Public: 05414734505475
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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
• Report Date (Section B): 11/06/2023

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: 08/31/2014
• Device Model Number: CD1257-40Q
• Device Lot Number: 3967648
• 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: 10/09/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2013
• 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: RIGHT VENTRICULAR (RV) LEAD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Male