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

Model Number CDVRA300Q

Device Problem Failure to Disconnect (2541)

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

Event Date 09/14/2023

Event Type  malfunction  

Event Description

Related manufacturer reference numbers: 2017865-2023-47561.It was reported that the patient presented in clinic for follow-up.Upon chest x-ray examination, it was found that the right ventricular (rv) lead had dislodged.During rv lead repositioning procedure, it was found that the rv lead helix failed to be retracted, and the rv lead was unable to be disconnected from the implantable cardioverter defibrillator (icd).Both the icd and the rv lead were explanted and replaced.There were no patient consequences.

Manufacturer Narrative

The reported event of failure to disconnect the lead from the header was confirmed.Final analysis found that the device was above elective replacement indicator (eri) upon receipt.Analysis revealed the right ventricular setscrew was fully stripped and contained septum material inside its hex cavity.The damage to the setscrew was consistent with having occurred during the procedure and resulting in failure to disconnect the lead from the header.

• Brand Name: ENTRANT VR
• 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: 17858883
• MDR Text Key: 324767774
• Report Number: 2017865-2023-47562
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032836
• UDI-Public: 05415067032836
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDVRA300Q
• Device Lot Number: P000152347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2022
• 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