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 Problems Premature Discharge of Battery (1057); Incorrect Interpretation of Signal (1543); Inappropriate/Inadequate Shock/Stimulation (1574)

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

Event Date 03/01/2024

Event Type  Injury  

Event Description

It was reported that patient's implantable cardioverter defibrillator (icd) exhibited inappropriate shock due to incorrect interpretation of signal during atrial fibrillation episodes.Premature battery depletion was also noted.The device was explanted and replaced.The patient was stable.

Manufacturer Narrative

The reported field event of inappropriate therapy, sensing issue and premature battery depletion was not confirmed.As received, the device was at end of service (eos) upon receipt.Review of the device data showed that the device delivered many consecutive hv therapies in a short period of time.The hv therapies were delivered appropriately, and the device acted normally given its programmed settings.A longevity calculation was performed and found the battery depletion was normal based on the device usage.Telemetry, impedance, sensing, pacing, capacitor maintenance, and high voltage (hv) output functions of the device were tested and found to be normal.No anomalies were found.

• 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: 18926949
• MDR Text Key: 337944193
• Report Number: 2017865-2024-35285
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734504355
• UDI-Public: 05414734504355
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/25/2024

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: 05/31/2021
• Device Model Number: CD1231-40
• Device Lot Number: S000074202
• 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: 03/18/2024
• Supplement Dates Manufacturer Received: 03/20/2024; 04/11/2024; 04/25/2024
• Supplement Dates FDA Received: 03/21/2024; 04/25/2024; 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2019
• 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
• Patient Outcome(s): Required Intervention