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

Model Number PM3120

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event 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.

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.

Manufacturer Narrative

Correction: aware date should have been (b)(6) 2024 not (b)(6) 2024.

• Brand Name: ALLURE CRT-P
• Type of Device: 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
• MDR Text Key: 331357904
• Report Number: 2017865-2023-95598
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734507882
• UDI-Public: 05414734507882
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/26/2023
• Supplement Dates Manufacturer Received: 02/08/2024
• Supplement Dates FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention