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

Model Number	5380
Medical Device Problem Code	Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
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 the asymptomatic patient's pacemaker was found to be in backup vvi mode during a monthly device check.The device was restored to normal functioning by reprogramming.The patient was stable following reprogramming and would continue to be monitored.
Additional Manufacturer Narrative
Correction: foreign should have been checked.Section - device not accessible for testing should have been indicated for method and 3221 - no findings available should have been indicated for results.Section g4 - pma number should have been included.

• 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: 7652676
• Report Number: 2017865-2018-09642
• Device Sequence Number: 10794541
• Product Code: LWP
• UDI-Device Identifier: 05414734006897
• UDI-Public: 05414734006897
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P910023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2014
• Device Model Number: 5380
• Device Lot Number: 3814630
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 09/29/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1