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

Model Number	CDVRA300Q
Medical Device Problem Codes	Failure to Interrogate (1332); Incorrect Measurement (1383); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implantable cardioverter defibrillator exhibited a measurement error with bluetooth telemetry loss.No intervention was performed.There were no patient consequences reported.
Additional Manufacturer Narrative
Correction: g3 - date received by manufacturer in 2017865-2026-02233 submitted on 2 feb 2026 should have been "12 feb 2026" instead of "14 jan 2026," as the issue was not actually confirmed until then.
Additional Manufacturer Narrative
Correction: upon review, the pulse generator should not have been submitted as a medical device report (mdr) as the reported event was not a device issue, which did not indicate a device malfunction and did not cause a serious event.

• Brand Name: ENTRANT VR
• Common Device Name: 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: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 24242488
• Report Number: 2017865-2026-02233
• Device Sequence Number: 18634526
• Product Code: NIK
• UDI-Device Identifier: 05415067032836
• UDI-Public: (01)05415067032836(10)P000159581(17)241231
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P030054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/01/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: CDVRA300Q
• Device Catalogue Number: CDVRA300Q
• Device Lot Number: P000159581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 02/12/2026; 03/18/2026; 04/01/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 02/27/2026; 03/18/2026; 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown