MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY VR, U1.6 DF1 US; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number CD1231-40

Device Problem Insufficient Information (3190)

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

Event Type  Injury  

Event Description

It was reported that the patient's device was explanted due to an unknown malfunction.The patient's condition was unknown.

Manufacturer Narrative

The device was returned due to unknown malfunction.There were no anomalies observed or confirmed within the lab.As received, the device was return elective replacement indicator (eri).Interrogation of the device revealed normal device functions.A longevity calculation was performed and found the battery depletion was normal based on the device usage.

Manufacturer Narrative

Correction g1: the awareness date of the previous of report should been april 25, 2024.

• Brand Name: FORTIFY VR, U1.6 DF1 US
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 18966507
• MDR Text Key: 338428315
• Report Number: 2017865-2024-35736
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507943
• UDI-Public: 05414734507943
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2024

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: 02/28/2013
• Device Model Number: CD1231-40
• Device Lot Number: 3485808
• 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: Not provided
• Initial Date FDA Received: 03/24/2024
• Supplement Dates Manufacturer Received: 04/04/2024; 05/20/2024
• Supplement Dates FDA Received: 05/13/2024; 05/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2011
• 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: RV LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male