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

Model Number	5156
Medical Device Problem Code	Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a follow up in clinic, the device was found to be in backup vvi (bvvi) mode.Abbott technical support was contacted, however, the device was unable to be successfully reprogrammed.The device was explanted and replaced to resolve the event.The patient was in stable condition.
Additional Manufacturer Narrative
Session records were provided for review by technical services.Analysis of the session records indicated that device reset occurred, leading to the device operating in bvvi mode.

• Brand Name: VERITY ADX SR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16984747
• Report Number: 2017865-2023-20759
• Device Sequence Number: 6871663
• Product Code: DXY
• UDI-Device Identifier: 05414734006767
• UDI-Public: 05414734006767
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2023

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: 07/31/2013
• Device Model Number: 5156
• Device Catalogue Number: 5156
• Device Lot Number: 3608681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2023
• Supplement Date Received by Manufacturer: 05/23/2023; 09/27/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 05/26/2023; 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown