MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE MP; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number	PM3542
Medical Device Problem Codes	Premature Discharge of Battery (1057); Capturing Problem (2891)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information requested, but not received.
Event or Problem Description
It was reported.A patient's pacemaker presented with high capture thresholds and premature battery depletion.The device was explanted and replaced in a procedure on (b)(6) 2023.Post-procedure the patient was stable.
Event or Problem Description
Related manufacturer reference number: 2017865-2024-00102.It was reported a patient's pacemaker presented with high capture thresholds and premature battery depletion.The left ventricular (lv) lead also had high capture thresholds.The pacemaker and lv lead were explanted and replaced in a procedure on (b)(6) 2023.Post-procedure the patient was stable.
Additional Manufacturer Narrative
Field event of capture problem and premature depletion were not confirmed.As received device was in normal range of operation and no anomalies were noted.Output, pacing and capture functions of the device were tested and found to be normal.Further analysis performed, including electrical, thermal and mechanical testing of the device did not find any anomaly.Assessment of total longevity was performed, and device was found to have appropriate remaining longevity.

• Brand Name: QUADRA ALLURE MP
• Common Device Name: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• 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: 18288415
• Report Number: 2017865-2023-94237
• Device Sequence Number: 17809487
• Product Code: NKE
• UDI-Device Identifier: 05414734510080
• UDI-Public: 05414734510080
• 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: 2021
• 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,Followup
• Report Date (Section B): 02/13/2024

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: 09/30/2021
• Device Model Number: PM3542
• Device Lot Number: P000100602
• 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: 11/17/2023
• Supplement Date Received by Manufacturer: 12/23/2023; 02/09/2024
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 01/02/2024; 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2020
• 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