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

Model Number CD2241-40

Device Problems Inappropriate or Unexpected Reset (2959); No Pacing (3268)

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

Event Date 08/24/2021

Event Type  malfunction  

Event Description

Related manufacturer reference number: 2017865-2021-30365.It was reported that the patient presented to the emergency room after receiving shocks for arrhythmia.Further interrogation revealed that the implantable cardioverter defibrillator exhibited backup vvi mode and no low-voltage output.Additionally, the right atrial lead exhibited loss of capture.The patient was in recovery.

• Brand Name: FORTIFY ST DR
• 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: 12465633
• MDR Text Key: 271224205
• Report Number: 2017865-2021-30364
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 6003342838
• UDI-Public: 6003342838
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2014
• Device Model Number: CD2241-40
• Device Lot Number: 3926688
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2013
• 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 STS
• Patient Age: 69 YR