MAUDE Adverse Event Report: ABBOTT 5356 VERITY DR, AB 20 55 184; IMPLANTABLE PACEMAKER PULSE-GENERATOR

Model Number	5356
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that set screw was unable to be removed from the device header during a device downgrade procedure.The device was explanted and replaced to resolve the event and the patient was in stable condition.
Additional Manufacturer Narrative
The reported event of could not untighten the atrial setscrew to remove the lead was confirmed.Analysis revealed that calcified blood was filling the a-setscrew inset.The calcified blood prevented the wrench from inserting into and engaging the setscrew inset to untighten the setscrew.Wrenches cannot penetrate the calcified blood.When the calcified blood was removed in the lab, a wrench could be fully inserted into the setscrew inset and the setscrew could be untightened normally.As a result, the stuck lead was successfully removed.The blood came through holes punched through the septum by the torque wrench at time of implant.

• Brand Name: 5356 VERITY DR, AB 20 55 184
• 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: 17701178
• Report Number: 2017865-2023-42425
• Device Sequence Number: 6631606
• Product Code: DXY
• UDI-Device Identifier: 05414734006835
• UDI-Public: 05414734006835
• 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 Implanted Year: 2008
• 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): 10/12/2023

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 Model Number: 5356
• 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: 08/23/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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