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

Model Number	5180
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/25/2018
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 when patient presented in clinic for a follow up visit, device was unable to be interrogated with an inductive wand only.Device has not been checked for the previous six months.A telemetry test in different rooms and with different programmers were attempted.Physician elected for device replacement due to normal elective replacement indicator.Device was explanted and a new device was implanted.No further information available.
Additional Manufacturer Narrative
Expiration date.Device manufacturing date.

• Brand Name: IDENTITY ADX SR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 7631645
• Report Number: 2938836-2018-07975
• Device Sequence Number: 16609701
• Product Code: LWP
• UDI-Device Identifier: 05414734006804
• UDI-Public: 05414734006804
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2011
• Device Model Number: 5180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 06/26/2018
• 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 Age: 78 YR