MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD2257-40Q FORTIFY ASSURA DR ICD_IDE_US; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number CD2257-40Q

Device Problem Delayed Charge Time (2586)

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

Event Date 10/24/2023

Event Type  Injury  

Event Description

It was reported that the implantable cardioverter defibrillator exhibited a delayed charge time.The device was explanted and replaced.The patient was in stable condition.

Manufacturer Narrative

The reported field event of long charge time was confirmed.Review of device data showed the device had a long charge time during charging for high voltage therapy.The cause of long charge time was consistent with the device performing multiple high voltage charges within a short period of time.The long charge time was not replicated during testing in the laboratory.Telemetry, impedance, sensing, pacing, and high voltage (hv) output functions of the device were tested and found to be normal.A capacitor maintenance was performed, and the charge time was normal.

• Brand Name: CD2257-40Q FORTIFY ASSURA DR ICD_IDE_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: 18128156
• MDR Text Key: 327990187
• Report Number: 2017865-2023-52326
• Device Sequence Number: 1
• Product Code: NVZ
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2023

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: 08/31/2014
• Device Model Number: CD2257-40Q
• Device Lot Number: 3955379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male