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

Model Number	5456
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event was estimated to have occurred in (b)(6) 2023.
Event or Problem Description
It was reported that during a follow up in clinic, an error message was received indicating programmer model 3510 is required to interrogate the device.The device was explanted and replaced due to normal battery depletion.The patient was in stable condition.
Additional Manufacturer Narrative
The field complaint of interrogation problem was confirmed.The device was received operating in backup mode.Analysis of device image indicated the device went into back up operation due to code corruption caused by low battery voltage.The device was cut open and it was determined that the battery voltage was at end of life (eol).Longevity assessment was performed based on field settings and found the implant duration exceeded projected longevity and was considered normal battery depletion.Functional testing was performed with new battery installed, and the device was found to be operating in normal condition.

• Brand Name: VERITY ADX XL VDR
• 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: 16455439
• Report Number: 2017865-2023-11345
• Device Sequence Number: 20294717
• Product Code: DXY
• UDI-Device Identifier: 05414734006910
• UDI-Public: 05414734006910
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2023

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: 01/31/2018
• Device Model Number: 5456
• Device Catalogue Number: 5456
• Device Lot Number: P000032338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/14/2023
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2016
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 1368/58; MERLIN PROGRAMMER
• Patient Sex: Unknown