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

Model Number	PM3242
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Arrhythmia (1721)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during routine generator exchange that the patient needed external defibrillation and the physician wondered if the pacemaker was responsible for the arrhythmia.The physician elected to explant and replaced the pacemaker.The patient was in unstable condition.
Additional Manufacturer Narrative
The reported event of output concerns was not confirmed.The device was received with normal output and telemetry communication.Analysis performed including cross talk test and output verification did not identify any functional issues.Electrical, longevity, and visual analysis was normal with no anomalies found.

• Brand Name: ALLURE QUADRA RF 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: 19554744
• Report Number: 2017865-2024-56640
• Device Sequence Number: 17825164
• Product Code: NIK
• UDI-Device Identifier: 05414734507912
• UDI-Public: (01)05414734507912(10)A000012081(17)170331
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: PM3242
• Device Lot Number: A000012081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2024
• 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: 05/28/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2015
• 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: 1456Q/86; MED-5076/52; MED-5076/58
• Patient Age: 70 YR
• Patient Sex: Male