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

Model Number CD1359-40QC

Device Problems Premature Discharge of Battery (1057); Inappropriate/Inadequate Shock/Stimulation (1574); No Apparent Adverse Event (3189)

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

Event Date 03/30/2023

Event Type  Injury  

Event Description

It was reported that the patient presented to the clinic for a follow-up on (b)(6) 2023.Upon interrogation, it was noted that the implantable cardioverter defibrillator (icd) delivered inappropriate shock therapy which caused to device to reach elective replacement indicator.There was premature depletion of battery on the icd.The device was explanted and replaced on (b)(6) 2023.The patient was in stable condition.

Event Description

New information received notes there was no malfunction noted on the implantable cardioverter defibrillator (icd) and the shock delivered was appropriate.The device reached normal elective replacement indicator and there was no premature battery depletion.The patient was in stable condition.

Manufacturer Narrative

Correction: this report is to retract 2017865-2023-17872 submitted on 18 apr 2023.This report was erroneously submitted.New information revealed device had no malfunction.

Manufacturer Narrative

The reported event of premature battery depletion was not confirmed.Rapid battery depletion was due to excess hv charges.The cause of the excess hv charges was due to the patient¿s physiology.Longevity analysis, telemetry, impedance, sensing, pacing, and high voltage (hv) output functions were normal with no anomalies found.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The device met specifications prior to leaving abbott manufacturing facilities.

• Brand Name: FORTIFY ASSURA VR 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: 16765758
• MDR Text Key: 313557282
• Report Number: 2017865-2023-17872
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: CD1359-40QC
• Device Lot Number: P000144173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention