MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ALLURE CRT-P; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, W/ CARDIAC RESYNCHRONIZATION

Model Number	PM3120
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
It was reported the asymptomatic patient presented in clinic.Upon interrogation, it was observed the patient's pacemaker had premature battery depletion.No known intervention was performed.The patient was stable.
Event or Problem Description
New information received indicated the patient's pacemaker was explanted and replaced on (b)(6) 2021 without issue.The patient was stable throughout.
Additional Manufacturer Narrative
The field complaint of premature discharge of battery was not confirmed.The device was received from the field with battery voltage at end of life.Analysis of device image indicated device operated at high pacing output settings as well as autocapture was enabled during implant period.When automatic settings are programmed, such as autocapture, the device would adjust itself to accommodate the patient¿s needs for pacing and thus affects the estimated longevity of the device.Device could not be interrogated during analysis due to low battery voltage.Further analysis performed after installing new battery revealed normal device characteristics.Longevity assessment was performed, and the implant duration exceeds the total projected longevity indicating normal battery depletion.

• Brand Name: ALLURE CRT-P
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, W/ CARDIAC RESYNCHRONIZATION
• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 12689417
• Report Number: 2017865-2021-34180
• Device Sequence Number: 11103496
• Product Code: NIK
• UDI-Device Identifier: 05414734507882
• UDI-Public: 05414734507882
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2022

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: 10/31/2018
• Device Model Number: PM3120
• Device Catalogue Number: PM3120
• Device Lot Number: A000039465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• 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: 10/05/2021
• Supplement Date Received by Manufacturer: 10/27/2021; 02/14/2022
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 11/16/2021; 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2017
• 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