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

Model Number CD2357-40Q

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2022

Event Type  Injury  

Manufacturer Narrative

The device is included in the battery performance alert advisory issued by abbott on (b)(6) 2017.

Event 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.

Manufacturer Narrative

The reported event of battery performance alert(bpa) was confirmed.The implantable cardioverter defibrillator (icd) was returned for analysis.Investigation revealed the bpa was a false positive.Prior to the event, the device had reset which cleared the device's usage data used in the bpa algorithm.This is normal and expected behavior when the data is cleared.No other anomaly was detected.

• Brand Name: FORTIFY ASSURA DR ICD, US
• Type of Device: 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16080946
• MDR Text Key: 306493244
• Report Number: 2017865-2022-51101
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/10/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: CD2357-40Q
• Device Catalogue Number: CD2357-40Q
• Device Lot Number: A000001173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 03/31/2023
• Supplement Dates FDA Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0003-2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 91 KG