MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ALLURE CRT-P; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number	PM3120
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that the patient had an initial pacemaker implant on (b)(6) 2016.On (b)(6) 2019, the patient presented for a follow-up in clinic and upon device interrogation it was noted that the elective replacement indicator was triggered.It was suspected to have been drained due to premature battery depletion.The device was explanted and replaced.The patient's condition was stable throughout the event.
Additional Manufacturer Narrative
Additional information: d10 interrogation of the device revealed it was at eol when received.A longevity calculation was performed and found the battery depletion was normal based on the device usage.The device was tested on the bench using automated testing equipment, and no anomalies were found.

• Brand Name: ALLURE CRT-P
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 9310464
• Report Number: 2017865-2019-16309
• Device Sequence Number: 17294863
• 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: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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: 07/31/2017
• Device Model Number: PM3120
• Device Catalogue Number: PM3120
• Device Lot Number: A000016380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 01/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 75