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

Model Number	5456
Medical Device Problem Codes	Incorrect Measurement (1383); Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During follow-up, the device was found to have reached its elective replacement indicator (eri) earlier than expected.Abbott technical support was contacted and confirmed that battery depletion was normal.It was suspected that overestimation occurred at a previous follow-up.The device was explanted and replaced to resolve the event.The device was found in back-up mode following device explant due to having reached end of service (eos).The patient was stable and there were no adverse consequences.
Additional Manufacturer Narrative
The field complaint of overestimation was not confirmed.The reported event of device found in backup vvi mode was confirmed.The device was received operating in backup mode.Analysis of the device image indicated autocapture was enabled during the implant period and the device went into backup mode after explant, which is consistent with exposure to cold temperature.When automatic settings are programmed, such as autocapture, the device would adjust itself to accommodate the patient¿s needs for pacing and thus affect the estimated longevity of the device.After the device was restored from backup mode, the device was found to be at elective replacement indicator (eri).Further analysis performed exhibited normal device characteristics without any anomalies.Longevity assessment was performed, and the implant duration exceeds total projected longevity indicating normal battery depletion.

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13443190
• Report Number: 2017865-2022-02518
• Device Sequence Number: 19344245
• Product Code: DXY
• UDI-Device Identifier: 05414734006910
• UDI-Public: 05414734006910
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 03/24/2022

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: 09/30/2008
• Device Model Number: 5456
• Device Catalogue Number: 5456
• Device Lot Number: 2920710
• 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: 01/19/2022
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2007
• 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
• Patient Sex: Unknown