MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ALLURE CRT-P; PACEMAKER PULSE GENERATOR

Model Number	PM3120
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 2017865-2021-29705.It was reported that the patient presented in clinic for a follow-up.Upon review, it was discovered that the pacemaker exhibited premature battery depletion and the left ventricular lead exhibited high capture thresholds.The left ventricular lead was explanted and replaced.Further information was requested however, was not provided.
Event or Problem Description
New information noted that the pacemaker was explanted.The patient was in stable condition post procedure.
Additional Manufacturer Narrative
Analysis was normal.No anomalies were found.
Event or Problem Description
New information noted that the pacemaker was explanted.Further information was requested however, was not provided.

• Brand Name: ALLURE CRT-P
• Common Device Name: PACEMAKER PULSE GENERATOR
• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 12423965
• Report Number: 2017865-2021-29705
• Device Sequence Number: 3652039
• Product Code: NIK
• UDI-Device Identifier: 05414734507882
• UDI-Public: 05414734507882
• 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: 2018
• Device Explanted Year: 2021
• 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,Followup
• Report Date (Section B): 11/30/2021
• 2 Devices were Involved in the Event: 1 2

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: 04/30/2019
• Device Model Number: PM3120
• Device Catalogue Number: PM3120
• Device Lot Number: P000050912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• 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: 08/17/2021
• Supplement Date Received by Manufacturer: 10/25/2021; 11/04/2021; 11/26/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 10/26/2021; 11/08/2021; 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2017
• 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: LV LEAD; LV LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown