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

Model Number	2525T
Medical Device Problem Codes	Failure to Capture (1081); Therapy Delivered to Incorrect Body Area (1508)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During an elective device exchange procedure, extracardiac muscle stimulation was observed.Because of this, the device was repositioned in the pocket, which resolved the muscle stimulation.The procedure was completed without further complication.The following day, a loss of capture was observed on the device.Upon investigation, the capture threshold returned to normal when the device was pocket was manually pressed.The physician elected to explant and replace the device.The patient was in stable condition.
Additional Manufacturer Narrative
Reported event of muscle stimulation or failure to capture were not confirmed.The device was received from the field with battery voltage above elective replacement indicator level.Analysis performed, including output verification as well as inspection of header and connectors indicated normal device characteristics without any anomalies that can contribute to reported event.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): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18057231
• Report Number: 2017865-2023-51496
• Device Sequence Number: 17660847
• Product Code: LWO
• UDI-Device Identifier: 05414734006224
• UDI-Public: 05414734006224
• 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: 2023
• Device Explanted Year: 2023
• 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): 12/21/2023

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: 06/30/2025
• Device Model Number: 2525T
• Device Lot Number: P000174939
• 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: 10/18/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• 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