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

Model Number	5386
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During an in clinic follow up, diagnostic data was not shown from the device.Technical support was contacted and reinterrogation of the device was recommended to clear the diagnostic data.No intervention has been performed at this time.The patient was stable.

• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 20370064
• Report Number: 2017865-2024-66515
• Device Sequence Number: 17080164
• Product Code: DXY
• UDI-Device Identifier: 05414734006903
• UDI-Public: (01)05414734006903(10)3526266(17)130430
• 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: 2011
• 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): 11/15/2024

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: 04/30/2013
• Device Model Number: 5386
• Device Lot Number: 3526266
• Was Device Available for Evaluation?: No
• 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: 09/18/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2011
• 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