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

Model Number	5376
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/10/2019
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 during a transtelephonic monitoring (ttm) check, no response was observed after magnet was placed on device.The expected longevity was calculated from last check in october and estimated approximately five months to elective replacement indicator assuming outputs and pacing percentage remained the same.Patient was asymptomatic and was scheduled for a in-clinic check.No further information available.
Additional Manufacturer Narrative
Correction: the device manufacture date date should have been 12/15/2006 rather than 12/13/2006.

• Brand Name: IDENTITY XL DR
• 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: 8276743
• Report Number: 2938836-2019-00600
• Device Sequence Number: 16525878
• Product Code: LWP
• UDI-Device Identifier: 05414734006880
• UDI-Public: 05414734006880
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2019

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: 06/30/2008
• Device Model Number: 5376
• Device Lot Number: 0002190535
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR