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

Model Number CD2357-40Q

Device Problems Incorrect Interpretation of Signal (1543); Use of Device Problem (1670); Low impedance (2285); Charging Problem (2892)

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

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2022-13614.It was reported that the patient presented remotely via merlin.Net.Review of the transmission revealed that the implantable cardioverter defibrillator attempted to deliver a shock for atrial fibrillation(af) with rapid ventricular rate(rvr).The shock was not delivered due to low right ventricular lead high voltage impedance.Lead insulation degradation was suspected.No intervention was performed.The patient condition was stable.

Manufacturer Narrative

The reported event of low high voltage lead impedance(hvli) was confirmed via review of device data but was not reproduced in the laboratory.The hvli measured within normal range while testing.The reported event of over current detection(ocd) was also confirmed via review of device data but it was not reproduced in the laboratory.The device was able to charge and deliver therapies normally during testing.The reported event of sensing anomaly could not be confirmed.Telemetry, impedance, sensing, pacing, and high voltage (hv) output functions of the device were tested and found to be normal.

Manufacturer Narrative

Further information was requested but not received.

Event Description

Related manufacturer reference number: 2017865-2022-13614 / 2017865-2022-19468.New information received notes that the implantable cardioverter defibrillator was explanted and replaced.No additional information was reported.

Event Description

New information notes that the patient was stable throughout the explant procedure.

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 14854220
• MDR Text Key: 296241191
• Report Number: 2017865-2022-13613
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734508094
• UDI-Public: 05414734508094
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/06/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: CD2357-40Q
• Device Catalogue Number: CD2357-40Q
• Device Lot Number: A000059963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 06/29/2022
• Supplement Dates Manufacturer Received: 07/27/2022; 08/24/2022; 08/30/2022
• Supplement Dates FDA Received: 08/16/2022; 08/25/2022; 09/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2018
• 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
• Treatment: TENDRIL
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 100 KG