MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2525T MICRONY II, SR+, PKGD/STER; PULSE-GENERATOR, SINGLE CHAMBER, SENSOR DRIVEN, IMPLANTABLE

Model Number	2525T
Medical Device Problem Codes	Failure to Capture (1081); Incorrect Measurement (1383)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient presented in-clinic.Upon examination patient's pacemaker was found to have lost capture and exhibited diagnostic anomaly of inability to display battery longevity.This resulted in a sustained patient bradycardia.The device was explanted on (b)(6) 2023.No further adverse patient consequences were reported.
Additional Manufacturer Narrative
The reported event of failure to capture and incorrect measurement were not confirmed.The device was received from the field with battery voltage above elective replacement indicator (eri) level.Analysis performed, including output verification and inspection of header and connectors indicated normal device characteristics without any anomalies that can contribute to reported events.Longevity assessment was performed, and device was in the normal range of operation with appropriate remaining longevity.

• Brand Name: 2525T MICRONY II, SR+, PKGD/STER
• Common Device Name: PULSE-GENERATOR, SINGLE CHAMBER, SENSOR DRIVEN, IMPLANTABLE
• 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: 18389870
• Report Number: 2017865-2023-95269
• Device Sequence Number: 3967513
• Product Code: LWO
• UDI-Device Identifier: 05414734006224
• UDI-Public: 05414734006224
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P970013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: 2525T
• Device Lot Number: P000044259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/01/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 12/24/2023
• Supplement Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2017
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown