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

Model Number	CD1257-40
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Following the battery performance alert (bpa) advisory, a bpa was received by the clinician and the device was explanted.The patient was stable before and after the procedure.
Additional Manufacturer Narrative
The device is included in the battery performance alert advisory issued by abbott on 28 august 2017.
Additional Manufacturer Narrative
The reported event of the battery performance alert (bpa) was confirmed.However, the bpa was falsely triggered and was caused by the device¿s firmware having been restored to normal operation in the field after entering bvvi mode.The cause of the bvvi mode remains unknown.No discernable cause of the bvvi operation has shown through interrogation or bench testing.The device¿s longevity was evaluated and determined to be normal.Interrogation of the device revealed the device was above the elective replacement indicator when received.The pacing, sensing, impedance, high voltage output, patient notifier was tested, and no anomaly was detected.

• Brand Name: FORTIFY ASSURA VR 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: 12957978
• Report Number: 2017865-2021-38471
• Device Sequence Number: 5410087
• Product Code: NVZ
• UDI-Device Identifier: 05414734505468
• UDI-Public: 05414734505468
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2022

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: 11/30/2014
• Device Model Number: CD1257-40
• Device Catalogue Number: CD1257-40
• Device Lot Number: 4081797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• 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: 11/29/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2013
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0003-2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DURATA RIGHT VENTRICULAR LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female