MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2525T MICRONY II, SR+, PKGD/STER; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	2525T
Medical Device Problem Codes	Premature Discharge of Battery (1057); No Pacing (3268)
Health Effect - Clinical Codes	Arrhythmia (1721); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via product receipt that the patient presented in clinic for follow-up.Upon interrogation, it was found that the pacemaker (pm) exhibited possible premature battery depletion.The pm was explanted and replaced.Patient condition was not provided.
Additional Manufacturer Narrative
The reported event of premature discharge of battery was not confirmed.The device at elective replacement indicator (eri) level was returned for analysis.Longevity assessment and battery longevity projection were normal with no anomalies found.
Event or Problem Description
It was reported via product receipt that the patient presented in clinic for follow-up.Upon interrogation, it was found that the pacemaker (pm) exhibited no pacing due to possible premature battery depletion.Patient had experienced bradycardia.The pm was explanted and replaced.Patient condition was not provided.

• Brand Name: 2525T MICRONY II, SR+, PKGD/STER
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• 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: 17115213
• Report Number: 2017865-2023-23032
• Device Sequence Number: 7200799
• Product Code: LWO
• UDI-Device Identifier: 05414734006224
• UDI-Public: 05414734006224
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P970013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2023

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: 10/31/2022
• Device Model Number: 2525T
• Device Catalogue Number: 2525T
• Device Lot Number: P000110737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• 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: 05/30/2023
• Supplement Date Received by Manufacturer: 11/06/2023; 11/16/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 11/08/2023; 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RV LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 YR
• Patient Sex: Female
• Patient Weight: 15 KG