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

Model Number	PM3160
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 2017865-2023-36102 it was reported that the patient presented for a follow-up in clinic.Upon interrogation, it was noted that the right ventricular (rv) lead exhibited failure to capture, failure to sense and low pacing impedance which may be due to header anomaly on the pacemaker.The pacemaker and the rv lead were explanted and replaced.The patient was stable.
Additional Manufacturer Narrative
The reported events of defective device, low impedance, and abnormal parameters were not confirmed.Final analysis found that the device was received from the field with battery voltage above elective replacement indicator (eri) level.Visual, electrical and mechanical analysis performed indicated normal functionality with no anomalies found.Further evaluation at various load impedance found the pacer was able to detect and measured the load changes with normal range.Longevity assessment was performed, and the device was in normal range of operation with appropriate remaining longevity.A device history record (dhr) review was performed, and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• Brand Name: ALLURE QUADRA MP
• 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: 17355920
• Report Number: 2017865-2023-36100
• Device Sequence Number: 12068726
• Product Code: NIK
• UDI-Device Identifier: 05414734509084
• UDI-Public: 05414734509084
• 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: 2023
• Device Explanted Year: 2023
• 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): 09/21/2023

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: 12/31/2023
• Device Model Number: PM3160
• Device Catalogue Number: PM3160
• Device Lot Number: P000150513
• 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: 07/09/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2022
• 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