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

Model Number	5256
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturer report number: 2017865-2023-51484.During a routine device exchange procedure, the set screws could not be loosened in order to remove the right ventricular (rv) lead from the header of the device.In addition, insulation damage was noted on rv lead.The rv lead was capped, and a replacement device and rv lead were implanted.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of could not untighten the ventricular setscrew to remove the lead was confirmed.Analysis revealed that off-center wrench insertions were being made through the septum causing punch-outs in the septum.The punch-outs landed inside of the setscrew inset.The excessive punch-outs along with the incorrect wrench insertions resulted in the physician stripping the setscrew inset such that the setscrew could not be untightened.For lab testing, the septum punch-outs were removed from the inset and correct full wrench insertion was made into the setscrew inset.The setscrew could then be untightened normally, and the stuck lead removed.The problem in the field was caused by the user's incorrect use of the torque wrench.No device anomalies were found.

• Brand Name: VERITY ADX XL
• 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: 18056466
• Report Number: 2017865-2023-51483
• Device Sequence Number: 5954135
• Product Code: DXY
• UDI-Device Identifier: 05414734006811
• UDI-Public: 05414734006811
• 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: 2010
• 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): 12/21/2023

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: 04/30/2011
• Device Model Number: 5256
• Device Lot Number: 2922373
• 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: 10/18/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2009
• 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