MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ENTRANT VR; IMPLANTABLE PACEMAKER PULSE-GENERATOR

Model Number CDVRA300Q

Device Problems Pacemaker Found in Back-Up Mode (1440); Environmental Compatibility Problem (2929); Inappropriate or Unexpected Reset (2959)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Further information was requested but not received.

Event Description

It was reported that the patient presented with a pacemaker that was in backup vvi.Further information was requested but not received.

Event Description

New information received on 19 dec 2023 indicated that the patient presented in clinic in backup vvi.The backup was caused by not programming mri mode before an mri.The device was reset, and the patient was stable.

• Brand Name: ENTRANT VR
• Type of Device: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• 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: 18320293
• MDR Text Key: 330467096
• Report Number: 2017865-2023-94702
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032836
• UDI-Public: 05415067032836
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/02/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: CDVRA300Q
• Device Lot Number: S000085784
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2022
• 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