MAUDE Adverse Event Report: ABBOTT IDENTITY ADX VDR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5480
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results, method, and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During an in clinic follow-up, the device had reached end of life (eol) and possible premature battery depletion was suspected.The device was explanted and replaced to resolve the event.The patient experienced no adverse consequences.
Additional Manufacturer Narrative
The field complaint of premature battery depletion was not confirmed.The device was received from the field without telemetry due to low battery level resulting from normal depletion.The device image could not be saved, and a request was made to the field for the image, but the information was not available.Session records provided from one year prior to explant indicated the lead impedance was lower than nominal due to patient's conditions.This affected the battery longevity estimation especially after the device had met projected longevity at that point.At this stage, the battery was more sensitive to patient's pacing needs.After replacing the original battery, the code was downloaded without anomaly.The device was evaluated under nominal and field conditions with results indicating normal current levels and no indication of premature depletion or longevity issues were detected.The pacing anomaly observed in the field is consistent with low battery voltage.Total projected longevity based on field settings is 5.92 years; implant duration is 6.76 years which exceeded projected longevity and considered normal battery depletion.

• Brand Name: IDENTITY ADX VDR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 9747201
• Report Number: 2017865-2020-02436
• Device Sequence Number: 11390838
• 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: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

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: 05/31/2013
• Device Model Number: 5480
• Device Catalogue Number: 5480
• Device Lot Number: 3558198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 07/29/2020
• 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