MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) NEUTRINO NXT HF; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CDHFA600Q

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 01/05/2023

Event Type  Injury  

Event Description

Related manufacturer report number: 2017865-2023-03137.Related manufacturer report number: 2017865-2023-03138.It was reported that a patient presented with high capture threshold, loss of capture, and loss of sensing on the right ventricular (rv) lead; and loss of capture, loss of sensing resulting in inappropriate mode switch on the atrial lead.On (b)(6) 2023, chest x-ray was performed and revealed that the implantable cardioverter defibrillator (icd) had migrated and the rv and atrial leads had dislodged.On (b)(6) 2023, the physician elected to reposition the icd and rv lead.During revision of the atrial lead, the helix would not extend.The physician elected to explant and replace the atrial lead.The patient condition was stable before, during, and after the procedure.

• Brand Name: NEUTRINO NXT HF
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 16243999
• MDR Text Key: 308129049
• Report Number: 2017865-2023-03139
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: CDHFA600Q
• Device Lot Number: P000153474
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2022
• 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