MAUDE Adverse Event Report: ABBOTT 2525T MICRONY II, SR+, PKGD/STER; PULSE-GENERATOR, SINGLE CHAMBER, SENSOR DRIVEN, IMPLANTABLE

Model Number	2525T
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	Fatigue (1849)
Date of Event	03/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During follow-up, the patient experienced fatigue.Premature battery depletion was suspected.The device was explanted and replaced to resolve the event.The patient was stable and there were no adverse consequences.
Additional Manufacturer Narrative
The reported event of premature discharge of battery was not confirmed.The device was received with normal output and telemetry communication.A longevity assessment was performed and found the device has reached elective-replacement level, consistent with the device settings and usage.Electrical and mechanical tests performed including telemetry communication and output verification did not identify any functional issues.The device was implanted for 4.02 years which exceeds its projected longevity and is consistent with normal battery depletion.

• Brand Name: 2525T MICRONY II, SR+, PKGD/STER
• Common Device Name: PULSE-GENERATOR, SINGLE CHAMBER, SENSOR DRIVEN, IMPLANTABLE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 21713442
• Report Number: 2017865-2025-38761
• Device Sequence Number: 9952489
• Product Code: LWO
• UDI-Device Identifier: 05414734006224
• UDI-Public: (01)05414734006224(10)P000112280(17)221031
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P970013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/19/2025

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: 10/31/2022
• Device Model Number: 2525T
• Device Lot Number: P000112280
• 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: 03/19/2025
• Supplement Date Received by Manufacturer: 05/15/2025; 06/19/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 06/06/2025; 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2020
• 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: Required Intervention
• Patient Sex: Unknown