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

Model Number	5456
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to an implant procedure, the device was unable to be interrogated using inductive telemetry.The device was not implanted and another device was implanted to resolve the event.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of failure to interrogate using inductive telemetry was not confirmed.The monthly current trend was normal, and the voltage was in the normal range of operation.Further electrical and mechanical analysis performed in nominal setting did not find any anomaly and the device was successfully able to be interrogated through inductive telemetry.Longevity assessment was performed, and the device was found to have appropriate remaining longevity.

• 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: 12590521
• Report Number: 2017865-2021-32590
• Device Sequence Number: 3787291
• 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
• 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): 11/16/2021

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: 03/31/2022
• Device Model Number: 5456
• Device Catalogue Number: 5456
• Device Lot Number: P000109142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• 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: 09/22/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2020
• 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