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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Interrogation of the device revealed it was above eri when received.Based on this information, the device was found to communicate appropriately with a merlin programmer and has not reached the elective replacement indicator (eri).The device is included in the premature battery depletion with implantable cardioverter defibrillator advisory notice issued by st.Jude medical on (b)(6) 2016.Further information was requested but not received.

Event Description

It was reported that the implantable cardioverter defibrillator was explanted due to product advisory.No further information was available.

Manufacturer Narrative

Additional information: a4, b5.

Event Description

New information received notes that the patient was discharged home.

• Brand Name: CD2257-40 FORTIFY ASSURA DR ICD_IDE_US
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11098255
• MDR Text Key: 224511939
• Report Number: 2017865-2020-25277
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734505543
• UDI-Public: 05414734505543
• Combination Product (y/n): N
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Model Number: CD2257-40
• Device Catalogue Number: CD2257-40
• Device Lot Number: 3969663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 01/05/2021
• Supplement Dates FDA Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 56