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

Model Number	5156
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During a device replacement procedure due to normal battery depletion, the physician attempted to unscrew the header set screw but was unsuccessful.The physician resolved the event by cutting the old lead and explanting the device.A new device and lead were then implanted.No malfunction was alleged against the lead.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of inability to untighten the setscrew to remove the lead was confirmed.Analysis revealed that calcified blood was filling the setscrew inset.The calcified blood was preventing the wrench from engaging the setscrew inset to untighten the setscrew.With the blood removed from the setscrew inset a wrench could then be fully inserted and engaged the setscrew inset and untightened the setscrew.The lead could then be removed.The blood came through a hole punched through the septum by the torque wrench at time of implant.

• Brand Name: VERITY ADX SR
• 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: 13099984
• Report Number: 2017865-2021-40204
• Device Sequence Number: 11280435
• Product Code: DXY
• UDI-Device Identifier: 05414734006767
• UDI-Public: 05414734006767
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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): 02/17/2022

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: 10/31/2010
• Device Model Number: 5156
• Device Catalogue Number: 5156
• Device Lot Number: 2915413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• 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: 12/16/2021
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2009
• 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