MAUDE Adverse Event Report: ABBOTT IDENTITY ADX XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5386
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During a routine device exchange procedure, it was noted the atrial lead was unable to be disconnected from the device header.It was suspected there was an issue with the device header, no issue was suspected with the atrial lead.The atrial lead was capped and not replaced.Replacement of the atrial lead is not anticipated.A new device was implanted.The patient was stable.
Additional Manufacturer Narrative
The reported event of unable to disconnect the atrial lead was confirmed.Analysis revealed that calcified blood was filling the inset of the atrial setscrew.Wrenches cannot penetrate the calcified blood.The wrench will just strip the portions of the inset it comes in contact with without engaging the setscrew.The inset was totally stripped by the user therefore the setscrew could not be untightened.Special tools were used to untighten the setscrew during lab analysis to remove the stuck a-lead from the connector.The blood came through holes punched through the septum by the torque wrench at time of implant.

• Brand Name: IDENTITY ADX XL DR
• 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: 15544604
• Report Number: 2017865-2022-40597
• Device Sequence Number: 20232198
• Product Code: DXY
• UDI-Device Identifier: 05414734006903
• UDI-Public: 05414734006903
• 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: 2007
• Device Explanted Year: 2022
• 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): 11/16/2022

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: 03/31/2008
• Device Model Number: 5386
• Device Catalogue Number: 5386
• Device Lot Number: 2954638
• 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: 09/13/2022
• Supplement Date Received by Manufacturer: 11/06/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2006
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ISOFLEX 1636T 58CM; ISOFLEX S LEAD
• Patient Sex: Unknown