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

Model Number	2525T
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced pocket pain due to their pacemaker.The pacemaker was explanted and replaced.The patient was stable throughout.
Additional Manufacturer Narrative
The device was returned due a reported event of patient pocket pain.Electrical testing of the device was found to be normal.Mechanical and visual examinations of the device were also found to be normal.There were no anomalies noted.

• Brand Name: 2525T MICRONY II, SR+, PKGD/STER
• Common Device Name: PULSE-GENERATOR, SINGLE CHAMBER, SENSOR DRIVEN, IMPLANTABLE
• Manufacturer (Section D): ABBOTT MEDICAL (CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT MEDICAL (CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 24767170
• Report Number: 2017865-2026-06827
• Device Sequence Number: 21120505
• Product Code: LWO
• UDI-Device Identifier: 05414734006224
• UDI-Public: (01)05414734006224(10)P000044260(17)190331
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P970013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: 2525T
• Device Lot Number: P000044260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2026
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 04/08/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TENDRIL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female