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

Model Number	5480
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/27/2020
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 pacemaker was interrogated and shown to have a longevity of approximately six months.10 days following, the device was at elective replacement indicator (eri) indicating the battery depleted faster than expected according to displayed longevity.The pacemaker was explanted and replaced.The patient was stable with no consequences.
Additional Manufacturer Narrative
The reported event of incorrect measurement and rapid drop in longevity estimate was not confirmed.Device was received in normal range of operation.Device image analysis indicated average monthly voltage and current trends were normal.There was evidence from the device image that autocapture feature was enabled which was the cause for eri flag.When automatic settings are programmed, such as autocapture, the device output would adjust itself to accommodate the patient¿s needs for pacing and thus affects the estimated longevity of the device.Further analysis did not find any anomaly and battery voltage was above eri.Total projected longevity was 7.9 years based on field settings.The implant duration was 7.05 years, the device has not yet reached eri and has appropriate remaining longevity.

• 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: 9711030
• Report Number: 2017865-2020-02002
• Device Sequence Number: 11598434
• 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): 06/02/2020

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: 04/30/2014
• Device Model Number: 5480
• Device Catalogue Number: 5480
• Device Lot Number: 3831832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 06/02/2020
• 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