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	11/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During follow-up, the device was found to be in backup mode.Premature battery depletion was also suspected.The device was explanted and replaced and the patient was in stable condition.
Additional Manufacturer Narrative
The reported event of premature battery depletion was not confirmed.The device was in backup mode when received for analysis.Device image showed that there were multiple bits flipped followed by transient non-maskable interrupt (nmi) that resulted to backup operation.Furthermore, a false elective replacement indicator (eri) was triggered 10 months prior to the explant date which resulted from transient low battery voltage, consistent with autocapture feature operating in high output mode.Clearing the eri message with the programmer restores normal device operation.Electrical test results indicated normal eri pacer functionality.Longevity assessment was performed based on nominal settings and it has met the projected longevity.The cause of the code corruption was undetermined.

• 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: 8113114
• Report Number: 2017865-2018-17939
• Device Sequence Number: 2324494
• 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
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/16/2019

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: 01/31/2014
• Device Model Number: 5480
• Device Lot Number: 3749420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 01/08/2019; 01/15/2019
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 01/14/2019; 01/16/2019
• 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