MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE CRT-P; NO MATCH

Model Number	PM3140
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient presented for scheduled procedure.Prior to procedure, it was noted that pacemaker's battery was exhausted in advance.The pacemaker was exchanged and replaced with new device.Patient condition was stable.
Additional Manufacturer Narrative
The reported event of longevity anomalies and premature discharge of battery was not confirmed.The device was received with normal output and normal telemetry communication.Analysis of the device image indicated the device was operating in high output mode, potentially reducing battery¿s capacity and resulting in fluctuation of battery voltage level measurements, which affects the longevity estimates.Electrical and mechanical tests performed indicated normal device functionality.Longevity assessment found the device was operating at normal voltage level, with appropriate remaining projected longevity.

• Brand Name: QUADRA ALLURE CRT-P
• Common Device Name: NO MATCH
• 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: 20397018
• Report Number: 2017865-2024-66824
• Device Sequence Number: 6517516
• Product Code: NIK
• UDI-Device Identifier: 05414734507899
• UDI-Public: (01)05414734507899(10)P000092176(17)210430
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 11/21/2024

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: 04/30/2021
• Device Model Number: PM3140
• Device Lot Number: P000092176
• 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: 09/19/2024
• Supplement Date Received by Manufacturer: 11/16/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2019
• 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