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

Model Number	PM3120
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented in clinic for a follow up.Device interrogation revealed premature battery depletion on the implantable cardioverter defibrillator (icd).The physician elected to explant and replace the icd.The patient was discharged from the hospital after the procedure.
Additional Manufacturer Narrative
Correction: for b1 and b2 nor selected for additional surgery.A device history record (dhr) review was performed, and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.Reported event of premature discharge of battery was not confirmed.The device was at elective replacement indicator (eri) level upon receipt.Electrical, longevity, and visual analysis was normal with no anomalies found.
Additional Manufacturer Narrative
Correction: aware date should have been (b)(6) 2024 not (b)(6) 2024.

• Brand Name: 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: 18395331
• Report Number: 2017865-2023-95598
• Device Sequence Number: 2761243
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: 03/31/2019
• Device Model Number: PM3120
• Device Lot Number: P000050676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 02/08/2024; 02/12/2024
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 02/09/2024; 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown