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

Model Number	5380
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	02/21/2011
Type of Reportable Event	Death
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.Further information was requested but not received.
Event or Problem Description
It was reported that the patient expired.There is no known allegation from a health professional that suggests the death was related to the device.It was reported that the cause of death is unknown.No further information was available.
Additional Manufacturer Narrative
Analysis was normal.No anomalies were found.

• Brand Name: IDENTITY ADX
• 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: 10607542
• Report Number: 2017865-2020-13775
• Device Sequence Number: 16438649
• Product Code: LWP
• UDI-Device Identifier: 05414734006897
• UDI-Public: 05414734006897
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

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: 09/30/2005
• Device Model Number: 5380
• Device Catalogue Number: 5380
• Device Lot Number: 0002668719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 11/13/2020
• 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: Death
• Patient Age: 89 YR