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

Model Number CDHFA300Q

Device Problems High impedance (1291); Failure to Sense (1559); No Pacing (3268)

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

Event Date 09/01/2023

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) exhibited failure to sense, no pacing, and high out-of-range pacing impedance.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 event of sensing, pacing and high impedance anomaly was confirmed.The device was returned in one piece for analysis.Impedance, sensing, and pacing output functions of the device were tested and found to be anomalous.Electrical testing revealed low internal voltage within the hybrid.An internal hybrid anomaly was found to be the cause of the reported event.No other anomalies were found.A 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: ENTRANT 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: 17713102
• MDR Text Key: 322991484
• Report Number: 2017865-2023-42579
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032850
• UDI-Public: 05415067032850
• 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: 05/16/2024

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: CDHFA300Q
• Device Lot Number: P000154412
• 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: 09/01/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 05/15/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2022
• 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