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 Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
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 in stable condition post 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 bpa was confirmed.Analysis showed normal battery voltage range and the bpa was a false positive alert.Device code was reloaded in the field, which cleared the device¿s usage data as part of the procedure.The bpa algorithm uses device usage history data for calculations and since that data got cleared after reloading code, a false bpa was triggered.This is normal and expected behavior when the device data is cleared.Interrogation of the device revealed the device was above eri when received.No other anomaly was detected.

• 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: 18238687
• Report Number: 2017865-2023-93580
• Device Sequence Number: 19659587
• Product Code: NVZ
• UDI-Device Identifier: 05414734505475
• UDI-Public: 05414734505475
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: 2023
• 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): 03/21/2024

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: 3967102
• 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: 11/10/2023
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2013
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 79 KG