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 Codes	Premature Discharge of Battery (1057); Pacing Problem (1439); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient presented to the emergency room with a pacemaker exhibiting an output rate issue.Interrogation revealed the pacemaker exhibited a battery impedance problem and that the battery was prematurely depleted.The pacemaker was explanted and replaced.The patient was stable before, during and after the procedure.

• 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: 19332694
• Report Number: 2017865-2024-41673
• Device Sequence Number: 7003688
• Product Code: LWO
• UDI-Device Identifier: 05414734006224
• UDI-Public: (01)05414734006224(10)P000069911(17)201031
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P970013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2024

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: 10/31/2020
• Device Model Number: 2525T
• Device Lot Number: P000069911
• Was Device Available for Evaluation?: No
• 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: 05/01/2024
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2018
• 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