MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. IDENTITY ADX VDR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5480
Medical Device Problem Codes	Premature Discharge of Battery (1057); Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During follow-up, the device was found in back-up mode due to low battery voltage.Premature battery depletion was suspected.Device replacement was anticipated to resolve the event.The patient was stable and there were no adverse consequences.
Event or Problem Description
It was reported that the device was explanted and replaced.
Additional Manufacturer Narrative
The reported event of backup operation was confirmed.The device was received in backup mode and the battery voltage was at its elective replacement indicator (eri).Analysis of device image indicated that the device reverted to backup operation due to a transient non-maskable interruption (nmi) reset from low battery voltage fluctuation because of an increase of pacing demand.Electrical test results indicated normal eri pacer functionality.A longevity assessment was performed and based on field parameters it was determined that the device has met its projected longevity.

• Brand Name: IDENTITY ADX VDR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8139544
• Report Number: 2017865-2018-18448
• Device Sequence Number: 1745965
• Product Code: LWP
• UDI-Device Identifier: 05414734006927
• UDI-Public: 05414734006927
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P880086
• 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,Followup
• Report Date (Section B): 02/19/2019

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: 01/31/2012
• Device Model Number: 5480
• Device Lot Number: 3173709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 12/20/2018; 02/07/2019
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 01/03/2019; 02/19/2019
• 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: Hospitalization; Required Intervention