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

Model Number CD2357-40Q

Device Problems Failure to Charge (1085); Energy Output Problem (1431); Incorrect Interpretation of Signal (1543); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 08/23/2020

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturer reference number: 2017865-2020-13526, 2017865-2020-13527.It was reported the patient presented remotely.Upon review of the transmission, it was observed the implantable cardioverter defibrillator inappropriately delivered anti-tachycardia pacing therapy as a result of incorrect interpretation of rhythm and failed to deliver shock due to the low impedance.The patient presented to the emergency room where it was observed the right ventricular lead and atrial lead had lead abrasion leading to over-sensing noise, as well as low defibrillation impedance on the ventricular lead.The right ventricular lead was capped and replaced on (b)(6) 2020 and the atrial lead had been surgically adhered to address the abrasion.The patient was stable.

Event Description

New information indicated the implantable cadioverter defibrillator was explanted and replaced on (b)(6) 2020.The patient was stable.

Manufacturer Narrative

Analysis was normal.No device anomaly found.

• 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
• MDR Report Key: 10528727
• MDR Text Key: 206777658
• Report Number: 2017865-2020-13528
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734508094
• UDI-Public: 05414734508094
• Combination Product (y/n): N
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/02/2020

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: 03/31/2017
• Device Model Number: CD2357-40Q
• Device Catalogue Number: CD2357-40Q
• Device Lot Number: A000002776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2020
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: 09/10/2020; 09/21/2020; 09/23/2020; 11/30/2020
• Supplement Dates FDA Received: 09/18/2020; 09/21/2020; 09/24/2020; 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR; TENDRIL STS; OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR; TENDRIL STS
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR