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 Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient's pacemaker presented with a diagnostic issue in which it struggled to make programming changes.The device was explanted and replaced in a procedure on (b)(6) 2024.Post-procedure the patient was discharged.
Additional Manufacturer Narrative
The reported event of incorrect measurement/unable to program device was not confirmed.The device was received from the field with battery voltage at elective replacement indicator (eri) level.The device was programmed and interrogated under nominal conditions successfully.Additional interrogation was not successful due to low battery voltage.Analysis performed after cutting open and attaching the device to a power source measured normal current level.Longevity assessment was performed based on nominal conditions and the device exceeded projected longevity indicating normal battery depletion.

• 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: 18862297
• Report Number: 2017865-2024-34393
• Device Sequence Number: 8294802
• Product Code: LWO
• UDI-Device Identifier: 05414734006224
• UDI-Public: 05414734006224
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P970013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• 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): 05/07/2024

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: 03/31/2018
• Device Model Number: 2525T
• Device Lot Number: P000027083
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2016
• 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 Age: 10 YR
• Patient Sex: Female