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

Model Number	5380
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During follow-up, the device longevity was measured and premature battery depletion was 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.Analysis of the device image revealed that eri had been triggered when the corresponding monthly battery voltage was normal.A false eri has occurred from transient high current drain caused by the device voltage approaching eri and brief increase in pacing activity or the autocapture being in high output mode.As-received, backup mode occurred, post explant due to low battery voltage and exposure to cold temperature.Downloaded product code pr9.7 to restore device out of the backup vvi mode.Analysis performed at nominal settings did not find any anomaly other than voltage being at eri level.Longevity assessment was performed, device was in the eri range of operation and exceeded the projected longevity.

• 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: 8329096
• Report Number: 2017865-2019-02081
• Device Sequence Number: 1717537
• Product Code: LWP
• UDI-Device Identifier: 05414734006897
• UDI-Public: 05414734006897
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2019

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: 07/31/2006
• Device Model Number: 5380
• Device Lot Number: 3000522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 04/30/2019
• 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