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

Model Number	5456
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the set screw was missing when the atrial lead was being connected to the device during implant.The device was explanted and replaced to resolve the event and the patient was in stable condition.
Additional Manufacturer Narrative
The reported event of device completed manufacturing and shipped without the atrial setscrew in the cavity was not confirmed.Analysis revealed the user was stripping the setscrew inset leaving behind the metal stripped from the setscrew on the bottom and inner side of the septum.The stripped metal from the setscrew is indication the setscrew was present and in place at the start of the procedure.The setscrew cannot be tightened while it is being stripped.The user then forced the wrench down into the setscrew inset still trying to tighten the setscrew which stuck the wrench in the setscrew.When the user pulled the wrench out of the device through the septum the stuck setscrew came out with it.The trail of stripped metal from the setscrew was left on the bottom and inner side of the septum.The user was not aware the setscrew came out of the device stuck to the wrench tip.This problem was caused by the user¿s incorrect use of the torque wrench.

• 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: 17200171
• Report Number: 2017865-2023-24227
• Device Sequence Number: 6666667
• Product Code: DXY
• UDI-Device Identifier: 05414734006910
• UDI-Public: 05414734006910
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 08/17/2023

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: 10/31/2024
• Device Model Number: 5456
• Device Catalogue Number: 5456
• Device Lot Number: P000169001
• 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: 06/08/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2023
• 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