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

Model Number	PM3140
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pocket Erosion (2013)
Date of Event	10/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented in clinic due to an eroded device pocket.The entire pacemaker (pm) system was explanted.The patient was stable throughout the procedure.
Additional Manufacturer Narrative
The reported field event of pocket erosion was not confirmed in the laboratory.The device was tested on the bench and using automated testing equipment, and no anomalies were found.The cause of erosion could not be traced to the device.

• 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: 18148527
• Report Number: 2017865-2023-52636
• Device Sequence Number: 20580124
• Product Code: NIK
• UDI-Device Identifier: 05414734507899
• UDI-Public: 05414734507899
• 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): 12/27/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: PM3140
• Device Lot Number: P000159935
• 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: 11/01/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: QUARTET.; TENDRIL STS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown