MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY VR, U1.6 SJ4 US; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number CD1231-40Q

Device Problems Premature Discharge of Battery (1057); No Apparent Adverse Event (3189)

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

Event Date 11/08/2023

Event Type  Injury  

Event Description

It was reported during in clinic follow up that the implantable cardioverter defibrillator exhibited premature battery depletion.The device was explanted and successfully replaced.The patient was stable and asymptomatic.

Manufacturer Narrative

The reported field event of premature battery depletion was not confirmed.Final analysis found the device was at elective replacement indicator (eri) upon receipt.Longevity analysis found the battery depletion to be normal.The device functioned normally during analysis.No anomalies were found.The event of longevity overestimation was confirmed.The overestimation was determined to be due to an estimation inaccuracy in the merlin programmer remaining longevity calculation.

Event Description

Related manufacturer reference number: 2017865-2024-32769.

• Brand Name: FORTIFY VR, U1.6 SJ4 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: 18221690
• MDR Text Key: 329166570
• Report Number: 2017865-2023-93350
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734504348
• UDI-Public: 05414734504348
• 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 Assistant
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

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: 03/31/2013
• Device Model Number: CD1231-40Q
• Device Lot Number: 3515235
• 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: 11/08/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2011
• 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: DURATA.
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female