MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) NEUTRINO NXT HF; NO MATCH

Model Number CDHFA600Q

Device Problems Defective Device (2588); Connection Problem (2900)

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

Event Date 08/12/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented in clinic for initial implant procedure.During procedure, it was found that the implantable cardioverter defibrillator (icd) header atrial port had a foreign substance that was unable to be removed and prevented full insertion of the lead.The icd was not implanted and an alternate near at hand was implanted instead on (b)(6) 2023.Patient condition was stable.

Manufacturer Narrative

The reported field event of header anomaly and lead connection issue was confirmed.Visual analysis shows the atrial ring spring was dislodged and pushed into the atrial lead bore.Device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• Brand Name: NEUTRINO NXT HF
• Type of Device: NO MATCH
• 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: 17674739
• MDR Text Key: 322669876
• Report Number: 2017865-2023-40913
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P030054
• 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
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDHFA600Q
• Device Lot Number: P000163478
• 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: 08/12/2023
• Initial Date FDA Received: 09/01/2023
• Supplement Dates Manufacturer Received: 01/05/2024
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2023
• 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