MAUDE Adverse Event Report: ABBOTT VERITY ADX XL; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5056
Medical Device Problem Codes	Pacemaker Found in Back-Up Mode (1440); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During an in clinic follow-up, the device was in backup vvi mode.The physician alleged the backup mode was due to electromagnetic interference.Abbott technical support reviewed the backup mode summary and alleged the backup mode was due to high battery impedance.The device is anticipated to be explanted and replaced to resolve the event.The patient was in stable condition and will continue to be monitored.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
Additional information received indicated the device entered backup mode due to reaching normal elective replacement indicator (eri) level.The device was explanted and replaced due to normal eri.The patient was in stable condition following the procedure.
Additional Manufacturer Narrative
The reported event of the pacemaker being in backup mode was confirmed.The pacemaker was received in backup operation with battery voltage above elective replacement indicator (eri) level.The device image was severely corrupted, and no data was available.The product code was reloaded, and the device was programmed to nominal settings.Electrical and mechanical analysis was performed which indicated normal device functionality.The backup condition was unable to be reproduced.Additionally, a longevity assessment was performed, and device was in the normal range of operation with appropriate remaining longevity.

• Brand Name: VERITY ADX XL
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11881531
• Report Number: 2017865-2021-19072
• Device Sequence Number: 3541282
• Product Code: DXY
• UDI-Device Identifier: 05414734006712
• UDI-Public: 05414734006712
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2013
• Device Model Number: 5056
• Device Catalogue Number: 5056
• Device Lot Number: 3613620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 06/16/2021; 09/20/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 06/24/2021; 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1