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

Model Number CD2357-40C

Device Problems Failure to Capture (1081); Failure to Sense (1559); No Pacing (3268)

Patient Problem Syncope/Fainting (4411)

Event Date 10/17/2022

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2022-44693.It was reported that the patient presented to the hospital for a follow-up on (b)(6) 2022 with syncope and a pause episode.During examination, it was noted that there no sensing and no capture on the implantable cardioverter defibrillator (icd) leading to no pacing.The right ventricular (rv) lead could not capture or sense as well.It could not be determined if this was an icd or rv lead issue.The physician explanted and replaced both the icd and the rv lead on (b)(6) 2022.The patient was in stable condition.

• 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: 15754665
• MDR Text Key: 303262519
• Report Number: 2017865-2022-44692
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734508063
• UDI-Public: 05414734508063
• 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
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: CD2357-40C
• Device Catalogue Number: CD2357-40C
• Device Lot Number: A000121406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• 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
• Treatment: TENDRIL
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female