MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD2257-40 FORTIFY ASSURA DR ICD_IDE_US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	CD2257-40
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented in clinic.Device interrogation revealed that the implantable cardioverter defibrillator was oversensing noise.The device was explanted and replaced.The patient was stable post procedure.
Additional Manufacturer Narrative
Correction: b1 should have been reported as adverse event, h1 should have been reported as serious injury, h6 health effect impact code should have been additional surgery.
Additional Manufacturer Narrative
The report of the event oversensing was confirmed by reviewing the device data.However, the reported event was caused by external (non-device related) factors.The device was tested in the laboratory; telemetry, impedance, sensing, pacing, and high voltage (hv) output functions of the device were found to be normal.

• Brand Name: CD2257-40 FORTIFY ASSURA DR ICD_IDE_US
• Common Device Name: 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 12853681
• Report Number: 2017865-2021-37335
• Device Sequence Number: 14726199
• Product Code: NVZ
• UDI-Device Identifier: 05414734505543
• UDI-Public: 05414734505543
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2023

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: CD2257-40
• Device Catalogue Number: CD2257-40
• Device Lot Number: 3952621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/01/2021
• Supplement Date Received by Manufacturer: 03/01/2023; 06/05/2023
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 03/01/2023; 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male