MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) IDENTITY XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5376
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	09/28/2018
Type of Reportable Event	Death
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 presented to the hospital for an elective system upgrade procedure and deceased during the surgery.There is no known allegation from a health care professional that suggests that the death was device related.The cause of death was unknown.No further information was reported.
Additional Manufacturer Narrative
The device was tested on the bench and no anomalies were found.

• Brand Name: IDENTITY XL DR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 7966684
• Report Number: 2017865-2018-15297
• Device Sequence Number: 11111297
• Product Code: LWP
• UDI-Device Identifier: 05414734006880
• UDI-Public: 05414734006880
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2007
• Device Model Number: 5376
• Device Lot Number: 0002289511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1488TC/46, (B)(4) ; 1488TC/52, (B)(4)
• Outcome Attributed to Adverse Event: Death
• Patient Age: 40 YR