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	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During implant procedure, the set screw of the header of the device was not able to be tightened.The device was not implanted, and a new device was successfully implanted to resolve this event.The patient was stable.
Additional Manufacturer Narrative
The reported event of the setscrew could not be tightened to secure the lead in the connector was confirmed.Analysis revealed that the user/physician was making incorrect torque wrench insertions into the setscrew inset.The wrench was being inserted off-center and at angles which caused punch-outs from the septum.These septum punch-outs landed in the setscrew inset and was filled up with the punch-outs.The punch-outs filling the inset blocked the wrench tip from inserting into the inset so that the setscrew could not be engaged or tightened.For lab testing, the punch-outs were removed out of the setscrew inset.A torque wrench could now be fully inserted into the inset, and the setscrew could be tightened normally down on the lead holding it securely in the device connector.This anomaly is related to the user/physician's incorrect use of the wrench.

• 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: 24258032
• Report Number: 2017865-2026-02272
• Device Sequence Number: 21232588
• Product Code: LWO
• UDI-Device Identifier: 05414734006224
• UDI-Public: (01)05414734006224(10)P000202382(17)260531
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P970013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 04/28/2026

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: 05/31/2026
• Device Model Number: 2525T
• Device Lot Number: P000202382
• 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: 01/16/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• 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