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 Codes	Inappropriate/Inadequate Shock/Stimulation (1574); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to the emergency room with an implantable cardioverter defibrillator that exhibited inappropriate shock.Additional information has been requested, but not received.
Additional Manufacturer Narrative
Correction: upon review, the implantable cardiac defibrillator should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction and did not cause a serious event.
Event or Problem Description
New information received noted that there was no device malfunction.

• 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: 14121238
• Report Number: 2017865-2022-08122
• Device Sequence Number: 17205934
• Product Code: NVZ
• UDI-Device Identifier: 05414734505543
• UDI-Public: 05414734505543
• Combination Product (Y/N): N
• 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): 04/22/2022

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: 3963615
• 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: 03/27/2022
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2013
• 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: BIOTRONIK RV LEAD.; TENDRIL LEAD.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR
• Patient Sex: Female